Clinical Trials

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67 studies in Division of Cardiovascular Diseases

  1. The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [Edwards Study 2010-12]

    Rochester, Minn. View Summary

    The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [Edwards Study 2010-12]

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    A prospective multi-center trial of patients undergoing aortic valve replacement for severe aortic stenosis. Patient cohorts will include the following groups based on operative risk for surgical aortic valve replacement: inoperable, high surgical risk (STS ≥ 8%), and intermediate risk (STS = 4-8%). The Edwards SAPIEN XT transcatheter heart valve (THV) system will be studied in patients deemed inoperable or intermediate risk. A subset of inoperable patients will be randomized to receive transcatheter aortic valve replacement (TAVR) with either the SAPIEN XT THV or the SAPIEN THV. The SAPIEN XT will be studied in intermediate risk patients randomized to receive TAVR with the SAPIEN XT or surgical AVR. The Edwards SAPIEN 3 THV will be studied in a non-randomized fashion in patients from all three risk groups. Data will be collected from all patients for up to five years following the valve replacement procedure.

    NCT ID:

    NCT01314313

    Who can I contact for additional information about this study?

    Rochester: Verghese Mathew, MD 800-471-1727
                        Rakesh Suri, MD 800-471-1727


  2. Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts.

    Rochester, Minn. View Summary

    Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts.

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study will compare two groups of subjects with complex abdominal aortic aneurysms. It will compare their clinical outcomes and quality of life measures. The group being treated in this study will have their aneurysms repaired by an endovascular approach using Zenith® Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients (historical cohort) whose complex aneurysms were treated by open surgical repair.

    NCT ID:

    NCT01937949

    IRB Number:

    13-002880

    Who can I contact for additional information about this study?

    Rochester: Gustavo Oderich, MDd 507-284-1575
                        Jan Hofer, RN 507-284-1575


  3. Biomarkers in Aortic Stenosis - B.A.S.S.

    Rochester, Minn., Jacksonville, Fla. View Summary

    Biomarkers in Aortic Stenosis - B.A.S.S.

    Location:

    Rochester, Minn., Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Patients with aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads who are referred for clinically-indicated echocardiographic exams at Mayo Clinic, in Jacksonville, Florida will be screened for participation in the study. The plan is to have 292 people take part in this study. This minimal risk study will consist of the recording of patient data, activity and bleeding questionnaires, and collection and analysis of blood samples.  Each blood sample will be analyzed for von Willebrand Factor antigen and activity, and von Willebrand Factor multimers, and BNP. Blood samples will be sent to the Mayo Special Coagulation Lab for analysis.

         Objective:

         This study seeks to assess the degree of association of the von Willebrand Factor activity indices and BNP to the severity of cardiac lesions, and to note a relationship between acquired bleeding the the hematologic abnormalities.  Plasma will be stored in attempt to develop new in vitro tests of von Willebrand factor (VWF) activity.

    NCT ID:

    NCT01334801

    IRB Number:

    09-006757

    Who can I contact for additional information about this study?

  4. A Phase Ib Randomized, Placebo-controlled, Double-blinded Study Evaluating the Safety of Ataciguat (HMR1766) in Patients With Moderate Calcific Aortic Valve Stenosis

    Rochester, Minn. View Summary

    A Phase Ib Randomized, Placebo-controlled, Double-blinded Study Evaluating the Safety of Ataciguat (HMR1766) in Patients With Moderate Calcific Aortic Valve Stenosis

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis. The primary focus of these studies will be on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without passing out), and determining whether treatment with Ataciguat results in significant reductions in blood pressure in this patient population.

    NCT ID:

    NCT02049203

    IRB Number:

    13-005387

    Who can I contact for additional information about this study?

    Rochester: Pam Engrav 507-255-6938
                        


  5. Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.

    NCT ID:

    NCT00911508

    IRB Number:

    09-004616

    Who can I contact for additional information about this study?

    Rochester: HRS Research Office 507-255-7456
                        


  6. A Phase IIa Study of the Safety, Tolerability and Hemodynamic Effects of a Continuous 6 Hour Intravenous Infusion of CXL-1427 in Hospitalized Patients With Systolic Heart Failure

    Jacksonville, Fla. View Summary

    A Phase IIa Study of the Safety, Tolerability and Hemodynamic Effects of a Continuous 6 Hour Intravenous Infusion of CXL-1427 in Hospitalized Patients With Systolic Heart Failure

    Location:

    Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a dose finding, randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure which will first evaluate up to four ascending dose levels of CXL-1427 in up to four cohorts of 8 patients each (the "Dose Escalation" cohorts). Subsequently, up to three of the initial dose levels of CXL-1427 may be assessed in the additional "Expansion" cohorts of up to approximately 16 patients to gain further confidence in the results at these dose levels. The CXL-1427 dose that will be evaluated in the first cohort will be 3µg/kg/min. The dose levels for the next three sequential Dose Escalation cohorts will be dependent on clinical safety and tolerability, as well as the results of the invasive hemodynamic measurements.

    NCT ID:

    NCT02157506

    IRB Number:

    14-004233

    Who can I contact for additional information about this study?

  7. Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

    Rochester, Minn. View Summary

    Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.

    NCT ID:

    NCT01685840

    IRB Number:

    13-002314

    Who can I contact for additional information about this study?

    Rochester: Wayner Miller, MD 507-284-3685
                        


  8. Micra Transcatheter Pacing Study

    Rochester, Minn. View Summary

    Micra Transcatheter Pacing Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The study is expected to be conducted in up to 70 sites located around the world, including up to 35 sites in the United States (U.S.).Participating geographies may include countries such as the U.S, Europe, China, India, Malaysia, and Japan. Up to 780 subjects will be enrolled (i.e. consented) to allow up to 720 subjects to be implanted enabling at least 600 subjects to be followed for at least 12-months post-implant. There are two primary objectives in this study (one safety and one efficacy). The primary safety objective of the study is to evaluate major complications related to the Micra system or procedure. The primary safety endpoint will be evaluated at 6-months (183 days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, will also be evaluated six months post-implant. This study also has a separate long term safety objective that will provide additional long-term safety data following potential regulatory submissions. All subjects will be followed until official study closure (official study closure is defined as when Medtronic and/or FDA requirements have been satisfied per the Clinical Investigational Plan and/or by a decision by Medtronic or regulatory authority).

    NCT ID:

    NCT02004873

    IRB Number:

    14-003022

    Who can I contact for additional information about this study?

  9. A Multicenter, International, Phase 3, Double-blind, Placebo-controlled, Randomized Study To Evaluate The Efficacy, Safety, And Tolerability Of Daily Oral Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg Or 80 Mg In Comparison To Placebo In Subjects Diagnosed With Transthyretin Cardiomyopathy (ttr-cm)

    Rochester, Minn. View Summary

    A Multicenter, International, Phase 3, Double-blind, Placebo-controlled, Randomized Study To Evaluate The Efficacy, Safety, And Tolerability Of Daily Oral Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg Or 80 Mg In Comparison To Placebo In Subjects Diagnosed With Transthyretin Cardiomyopathy (ttr-cm)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study will investigate the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg tafamidis meglumine soft gel capsules in comparison to placebo and given once daily, in addition to standard of care, for 30 months in subjects diagnosed with transthyretin cardiomyopathy (familial and wild-type). The study is designed to assess the potential for benefit from treatment with tafamidis relative to placebo based on all-cause mortality and frequency of cardiovascular-related hospitalizations.

    NCT ID:

    NCT01994889

    IRB Number:

    13-000543

    Who can I contact for additional information about this study?

  10. Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial

    Rochester, Minn. View Summary

    Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Prior studies showed that, if a moderate/large Patent Ductus Arteriosus (PDA) is still present at 5 days after birth (among infants delivered at 23 and 0/7 to 25 and 6/7 weeks gestation) or at 7 days after birth (among infants delivered at 26 and 0/7 to 27 and 6/7 weeks gestation), it will persist for at least another 4-12 weeks if it is left untreated.

    NCT ID:

    NCT01958320

    IRB Number:

    13-001922

    Who can I contact for additional information about this study?

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