Clinical Trials

The study will determine the benefit of Colchicine versus placebo for cardiac surgery patients on the post-operative development of atrial fibrillation and post-pericardiotomy syndrome.

Primary Objective. Colchicine will reduce the composite endpoint of incidence of post-operative atrial fibrillation and post-pericardiotomy syndrome at 3 months following cardiac surgery.

Secondary Objectives.

1. Colchicine will reduce the incidence of constrictive physiology on echocardiography at 3 months following cardiac surgery.
2. Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3 months following cardiac surgery with the use of colchicine.

The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation. Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter. Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter. The study will compare the two drugs for up to three years after ...

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Is the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) superior to the current state-of-the-art therapy with either rate control or rhythm control drugs for a) reducing the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest (primary endpoint; previously the key secondary endpoint) and b) decreasing total mortality (secondary endpoint; previously the primary endpoint) in subjects with untreated or incompletely treated AF warranting therapy?

The goal of this clinical trial is to compare the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. This procedure is for patients with non-valvular atrial fibrillation who are at increased risk for stroke, but have a reason to seek an alternative to blood thinning medications. This clinical trial will compare the safety and efficacy of the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. Participants in this trial will be randomly assigned one-to-one (like flipping a coin) for treatment with either the Laminar Left Atrial Appendage Closure System ...

The purpose of this registry is to collect observational data for evaluating the outcomes related to the use of new target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, as they are used in broad patient populations following approval by clinical  research studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent.

The purpose of this study is to evaluate the construct validity of the Knowledge about Atrial Fibrillation Survey (KAFS). The study also aims to test the internal consistency reliability of the KAFS.

The purpose of this study is to determine the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS) and to generate critical, practical knowledge about the feasibility of conducting a randomized trial to test the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of Atrial Fibrillation (AF).

To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.

The main objective of this study is to compare a dual antithrombotic therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel,or ticagrelor 110mg dabigatran etexilate dual antithrombotic therapy (DE-DAT), and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a triple antithrombotic therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus ASA ≤ 100mg q.d. (warfarin-TAT) in patients with atrial fibrillation that undergo a percutaneous coronary intervention with stenting (elective or due to an acute coronary syndrome).

The study aims to show non-inferiority of both doses of DE-DAT when compared to Warfarin-TAT in efficacy and safety. Efficacy will be ...

This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .

This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related effect on procedural outcome.

OBJECTIVES:

Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF. Results from the DECAAF study show that one of the most important predictors of ablation outcome was the degree of ablation of the fibrotic tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better the outcome. These results were the impetus for the primary outcome ...

The objective of this project is to develop and evaluate an anticoagulation therapy decision aid for patients with non valvular atrial fibrillation.

The objectives of this study are: (1) to analyze beat-to-beat variability and the variations of R-R interval to pre-preceding R-R interval (RRp/RRpp) ratio of left ventricular (LV) function by strain imaging (2D speckle tracking echocardiography) in patients with atrial fibrillation (AF) undergoing electrical cardioversion(ECV) or radiofrequency catheter ablation (RFCA) as a predictor of a recovery of LV function and volume after restoration of sinus rhythm , (2) to evaluate left atrial mechanics as a predictor of for AF recurrence after electrical cardioversion (ECV) or radiofrequency catheter ablation (RFCA)

The purpose of this study is to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

The purpose of this study is to assess termination of atrial fibrillation (AF) following delivery of cold treatment to the oblique sinus using an experimental cooling module.

The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

The purpose of this study is to learn about patients' values and perceptions of content that should be included in initial atrial fibrillation education, identify their recommendations for approaches to education, and teach them features of healthcare provider communication that make it possible for patients to better manage their atrial fibrillation and self-care activities. Additionally the study aims to learn about healthcare providers' perceptions of content they believe to be important, and identify approaches to education that can be used in their practice.

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

The purpose of this study is to evaluate the effectiveness of MayoExpertAdvisor, a knowledge delivery tool, to improve provider adherence to guidelines of best practice for patients with hyperlipidemia, atrial fibrillation and heart failure.

The purpose of this study is to determine arterial stiffness in patients with atrial fibrillation (AF) using acoustic radiation vibrometry, to compare acoustic radiation force (ARF) measurements in patients with AF before and after electrical cardioversion, and to determine whether arterial stiffness predicts recurrence of AF after cardioversion.

The purpose of this study is to evaluate the outcomes of a community placed atrial fibrillation (AF) screening and education program

Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

The purpose of this study is to evaluate the number of leaks from the LA into the LAA, and the size of each. 

The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for ...

The purpose of this study is to provide safety and effectiveness data regarding the use of the Adagio System in the treatment of Persistent Atrial Fibrillation (PsAF).

VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.

The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.

The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected  atrial fibrillation (AF).

The purpose of this study is to assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.

The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation System in accessing and closing off the left atrial appendage (LAA) using a minimally invasive epicardial access approach.

A minimum of 30 participants will be included in this study, which is being performed at a maximum of 8 centers in Canada and the United States. (A maximum of 5 participants at 4 US centers will be enrolled)

Participants will be considered for this treatment if their doctor(s) have determined they have documented non-valvular atrial fibrillation and are at increased risk for ...

The purpose of this study is to develop an evidence-based decision aid for patients with nonvalvular chronic atrial fibrillation.

To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure Technology.

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelectTM PFA System for the treatment of paroxysmal and persistent atrial fibrillation.

The purpose of this study is to compare the Sentinel® Cerebral Protection System to the standard of care (no cerebral protection) in patients undergoing atrial fibrillation (AF) catheter ablation.

This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.

The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied.

A second phase of the study will treat up to ...

The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.

The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).

The purpose of this study is to help researchers better understand the impact of wearable devices on patient experience and clinical trends following a cardioversion.

The purpose of this study is to evaluate the safety and effectiveness of AtriCure's CryoICE Ablation System in performing the Cox-Maze III Lesion set surgical procedure, in conjunction with LAA exclusion using ArtiCure's AtriClip device.

The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.

The purpose of this study is to determine and compare the safety and efficacy of transcutaneous afferent patterned stimulation (TAPS) and respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) therapies for the reduction of paroxysmal atrial fibrillation (AF) burden.

The purpose of this study is to screen high-risk subjects with annual prolonged cardiac monitoring to determine the rate of subclinical atrial fibrillation detection.
 

The purpose of this study is to evaluate stellate ganglion blockade with local anesthetic intraoperatively to reduce the development of postoperative atrial fibrillation.

Atrial fibrillation is an important postoperative complication following cardiac surgery despite many attempts to reduce the incidence. Temporary stellate ganglion blockade reduces ventricular arrythmias in various circumstances with animal and early human data also showing an effect on the development of atrial fibrillation. The duration of arrythmia control outlasts the expected duration of local anesthetic effect by a significant duration.  Stellate ganglion blockade has potential for great impact reducing the burden of POAF including large cost savings, reduction in ...

The purpose of this study is to assess the immediate effect of cardioversion on both the tricuspid and mitral annular dynamics and size in patients with atrial fibrillation, and to compare the annular dynamics and dimensions in both the tricuspid and mitral valves immediately before and after cardioversion in patients with atrial fibrillation using 3D transesophageal echocardiography.

The purpose of this study is:

1. To assess whether corrective rhythm procedure during robotic mitral valve repair produce reliable long-term results.
2. To determine the incidence of new onset atrial fibrillation after robotic mitral valve repair.
3. To determine whether rhythm plays a role in long term valvular function.
4. As a secondary aim, we would like to study the outcomes of small subset of patients (10 patients) who underwent robotically assisted left atrial mass removal.
5. As a secondary aim, we also plan to look at our robotic patients and compare them to the conventional repair cohort to study the various echocardiographic parameters.

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation.

The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

1. The primary purpose of this study is to assess the comparative effectiveness of the following 4 approaches to promote high-quality SDM for at-risk patients with AF:  a PDA alone, (2) an EDA alone, (3) a combination of a PDA and an EDA, and (4) control with neither a PDA nor an EDA.

The purpose of this study is to determine if an atrial fibillation (AF) detection intervention in men and women at least 70 years of age with undiagnosed AF or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.

The purpose of this study is to characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable Insertable Cardiac Monitor (ICM) prototype device.

The purpose of this study is to compare the safety and effectiveness of Edoxaban to Warfarin when used in patients with a non-valve related atrial fibrillation undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.

The purpose of this study is to assess the decline in cognitive function using standardized neurocognitive assessment in Atrial Fibrilation patients treated with Apixaban vs Warfarin.

The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy.

The purpose of this study is to assist patients and clinicians weigh the potential harms and benefits of different treatment options for atrial fibrillation.  The plan is to develop an evidence-based decision aid for use in clinical encounters. The goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about treatment options for atrial fibrillation. It should also reflect the values and preferences of the informed patient.

The purpose of this study is to prospectively determine if direct current cardioversion (DCCV) results in myocardial injury as assessed by changes in high sensitivity cardiac troponin T (hs-cTnT) assay.

The aims of this investigation are:

To assess the predictive value (and accuracy) of clinical and physiologic preoperative variables in identifying patients at risk for the development of new-onset atrial arrhythmia after cardiac surgery.

To assess the feasibility of a physiological risk model based on clinical and echocardiographic indexes to predict post-operative AF.

To assess the role of prophylactic agents in the prevention of new-onset postoperative POAF

To assess the economic impact of new-onset postoperative AF:

• Length of hospital stay (will be measured as fractions of days)

• Hospital cost (will be measured in standardized dollars)

• Resource utilization (will be measured by resource-based relative-value units)

To assess the outcome ...

The purpose of htis study is to see if PGx testing will help to determine better ways for doctors to use apixaban treatment.

The purpose of this 12 week study is to assess the safety of oral IW-1973 when administered to patients with heart failure with preserved ejection fraction (HFpEF) and its effect on peak exercise capacity, both in all patients and in patients without permanent or persistent atrial fibrillation

The purpose of the study is collect specimens for future studies to identify markers circulating in the blood that are associated with the development of further complications of heart disease.

The purpose of this study is to collect surgically removed atrial tissue for genetic, pathologic, metabolic, and molecular studies in patients with or without a history of atrial fibrillation.

The purpose of this study is to examine if the measurements that we make by current standards for patients with both aortic stenosis (narrowed aortic valve) and atrial fibrillation underestimate severity of aortic stenosis and if that has any effect on timing of aortic valve surgery

We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

The purpose of this study is to verify that high Premature Ventricular Complex (PVC) burden is associated with increased risk of stroke and/or Transient Ischemic Attack (TIA), to examine outcomes such as stroke/TIA, atrial fibrillation/flutter, and all-cause mortality associated with PVCs, and to evaluate whether PVCs are associated with development of appendage dysfunction.

The primary purpose of this study is to determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

The purpose of this study is to determine the incidence of atrial and ventricular arrhythmias in patients with hypertrophic cardiomyopathy, with and without sleep apnea.

The purpose of this study is to identify and characterize heart rhythm disorders including atrial arrhythmias such as atrial fibrillation, ventricular arrhythmias such as ventricular tachycardia, conduction abnormalities, etc. among patients with spontaneous coronary artery dissection (SCAD).

The purpose of this study is to determine if apixaban given for 6 months is safer than Vitamin K Antagonist (VKA) given for 6 months in terms of major bleeding and non-major bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or in atrial fibrillation patients undergoing a procedure to open up a blood vessel in the heart (percutaneous coronary intervention). All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel). All patients would be treated for an intended 6 months.

The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.