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ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction (ARTEMIS)
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to is to demonstrate the efficacy and safety of ziltivekimab in reducing the risk of major adverse CV events when initiated as early as possible in adult patients with ST-elevation and non-ST-elevation myocardial infarction.
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DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF)
Scottsdale/Phoenix, Ariz.
Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and are resistant to diuretic therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.
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Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II (COSIRA-II) (COSIRA-II)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization.
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Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects with a Recent History of Acute Myocardial Infarction (SOS-AMI)
Scottsdale/Phoenix, Ariz.
The primary objective of the study is to assess the clinical effectiveness of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI.
The secondary objective is to assess the safety of self-administration of selatogrel.
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Endocardial Delivery Of XC001 Gene Therapy For Refractory Angina Coronary Treatment: A 26-Week (With 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study To Evaluate Efficacy And Safety (EXACT2)
Scottsdale/Phoenix, Ariz.
This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD.
Part 1 of the study is comprised of 3 subjects with RA (CCS class II-IV) who will receive 4×1011 viral particles (vp) XC001. An Independent Data Monitoring Committee (IDMC), the committee will review safety and feasibility data and approval to commence enrollment in Part 2 of the study.
Part 2 is a randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53). It is estimated that approximately 106 subjects will be randomized to result in 100 evaluable subjects. All subjects enrolled in Part 1, as well as Part 2 will follow all screening and safety monitoring procedures for up to 12 months (Table 2), and will be included in the safety analysis of the study.
Closed for Enrollment
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A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects (COAPT)
Scottsdale/Phoenix, Ariz.
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation.
Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device.
As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints)
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A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events when Evolocumab (AMG 145) is Used in Combination with Statin Therapy in Patients with Clinically Evident Cardiovascular Disease (FOURIER)
Scottsdale/Phoenix, Ariz.
The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.
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A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a
Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human Vascular Endothelial Growth Factor, to the Ischemic Myocardium of Subjects with Angina Pectoris Secondary to Coronary Artery Disease that is Refractory to Drug Therapy and Unsuitable for Revascularization (EXACT)
Scottsdale/Phoenix, Ariz.
The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).
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A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction (MI-NSTEMI)
Scottsdale/Phoenix, Ariz.
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
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A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome (AEGIS-II)
Scottsdale/Phoenix, Ariz.
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
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A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy with Dabigatran Etexilate (110mg and 150mg b.i.d.) plus Clopidogrel or Ticagrelor versus Triple Therapy Strategy with Warfarin (INR 2.0 - 3.0) plus Clopidogrel or Ticagrelor and Aspirin in Patients with Non Valvular Atrial Fibrillation (NVAF) that have Undergone a Percutaneous Coronary Intervention (PCI) with Stenting (REDUAL-PCI)
Scottsdale/Phoenix, Ariz.
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 determined by comparing a composite death and thrombotic event rate of death, myocardial infarction, stroke and systemic embolism. In addition, comparisons will be made of the rates of clinically relevant bleeding, assessed using the modified International Society of Thrombosis and Haemostasis (ISTH) major classification.
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A Prospective, Randomized, Double-Blinded, Active-Control and Unblinded Standard of Care (SOC) Controlled Study to Determine the Efficacy and Safety of Targeted Intramyocardial Delivery of Autologous CD34+ Cells (Auto-CD34+ Cells) for Increasing Exercise Capacity During Standardized Exercise Testing in Subjects with Refractory Angina Pectoris and Chronic Myocardial Ischemia (RENEW)
Scottsdale/Phoenix, Ariz.
The purpose of the study is to assess the safety and effectiveness of targeted delivery of Auto-CD34+ stem cells into heart muscle tissue to increase exercise time and decrease anginal symptoms in patients who have angina resistant to treatment and chronic heart muscle death.
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An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
Scottsdale/Phoenix, Ariz.
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.
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GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches – The GORE RELIEF Clinical Study (RELIEF)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate Patent Foramen Ovale (PFO) closure for migraine headache relief using the GORE® CARDIOFORM Septal Occluder after a trial of oral anticoagulation therapy vs. placebo for a 6 week period.
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Transendocardial Injection of Ixmyelocel-T in Subjects with Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM) (ixCELL DCM)
Scottsdale/Phoenix, Ariz.
This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.
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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP™ Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP™ Heart Failure Trial)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects will precede the randomised phase.
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Wellness Program to Improve Staff Joy, Kindness, and Gratitude for Personal and Professional Wellbeing (JKG)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to develop a wellness program to improve the wellbeing of staff and trainees.
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