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Cardiovascular Clinical Trials

 

For information about participating in a cardiovascular clinical trial at Maimonides Heart & Vascular Institute, please call (718) 283-7709.

 

Open Clinical Trials

Research and
Registries
Description
CONVERGE

Convergence of Epicardial and Endocardial Radiofrequency Ablation for the treatment of symptomatic persistent Atrial Fibrillation.

HeartMate PHP™
(SHIELD)

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Navigate X4

Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads.

OPTISURE

This post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients that have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia, and who meet all the inclusion/exclusion criteria.

PARADISE- MI
(LCZ696G2301)

A multi-center, randomized, double-blind,active-controlled,parallel-group Phase 3 study to evaluate the eficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following and acute myocardial infarction.

PERIGON

A multi-center, non-randomized trial to determine the safety and effectiveness of the Model 400 aortic valve bioprosthesis in patients with aortic valve disease.

PORTICO

Prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods. This trial includes both high-risk and extreme-risk patients.

PreDetermine

Identify a series of genetic markers and biomarkers that specifically predict risk of arrhythmic death as compared to other causes of mortality among CAD patients.

S-ICD Post Approval
Study

A non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new candidates for the S-ICD System.

Cath PCI Registry

Assesses the characteristics, treatments and outcomes of cardiac disease patients who receive diagnostic catheterization and/or percutaneous coronary intervention (PCI) procedures. This powerful tool captures the data that measure adherence to ACC/AHA clinical practice guideline recommendations, procedure performance standards and appropriate use criteria for coronary revascularization.

ICD Registry

A nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillator (CRT-Ds).

LAAO Registry

The first national registry capturing data on left atrial appendage occlusion procedures to assess real-world procedural outcomes, short and long-term safety, comparative effectiveness and cost effectiveness.

STS/ACC TVT
Registry

A collaboration between the Society for Thoracic Surgeons and the ACC, monitors patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures – emerging treatments for valve disease patients. Employing state-of-the-art heart valve technology, transcatheter heart valve procedures provide new treatment options for patients who are not eligible for conventional heart valve replacement or repair surgery.

Intermacs LVAD
Registry

Intermacs is a North American registry for the clinical outcomes of patients who receive an FDA-approved mechanical circulatory support device to treat advanced heart failure.

Gore Conformable
Endograft

This endovascular treatment for the thoracic aorta provides a less invasive option for diseases of the descending thoracic aorta. This treament is available for aneurysms and all Type B dissections.

 Imperial Trial

This prospective clinical trial compares drug eluding stents to drug coated stents in peripheral vascular diseases of the lower extremity.

Anchor Registry

Assesses patients undergoing initial (primary) endovascular repair of an AAA where the investigator believes the proximal aortic neck is challenging such that the risk of failure or fixation and/or sealing is great enough so that the use of the Heli-FX EndoAnchor System is warranted.