Clinical Trials

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Current Clinical Trials

ARRAY Study (NCT03439514)

A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (PI: Emerson Perin, MD, PhD)

CardiAMP™ Heart Failure Trial (NCT02438306)

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure  (Sponsor: BioCardia, Inc) (PI: Emerson Perin, MD, PhD)

A clinical trial for patients suffering from heart failure after a previous heart attack.

CONCERT-HF (NCT02501811) | Enrollment Closed

This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.

cVAD Study

Ongoing, observational, prospective, multicenter, records review study of routine clinical care and outcomes for patients who received support from one or multiple ABIOMED, Inc. hemodynamic support devices in routine clinical care. (PI: Andrew Civitello, MD)

DREAM-HF 1 (NCT02032004) | Enrollment Closed

The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction. (PI: Emerson Perin, MD, PhD)

Heart FID (NCT03037931)

Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency  (PI: Reynolds Delgado, MD)

LESS-VT | FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study (NCT03490201)

This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired. (Sponsor: Abbott) (PI: Nilesh Mathuria)

OPTIMIZE IDE for the Treatment of ACS (NCT03190473) | Enrollment Closed

The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study.

This study is being conducted to test the Svelte Drug Eluting Coronary Stent by comparing it to any commercially approved Abbott Vascular Xience or Boston Scientific Promus Drug Eluting Coronary Stent (control DES). The condition being studied is symptomatic ischemic heart disease, such as angina or a previous myocardial infarct, which is plaque formation in the arteries of your heart that requires treatment. (PI: Emerson Perin, MD, PhD)

SENECA (NCT02509156) | Enrollment Closed

The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC).

The secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.

PORTICO IDE (NCT02000115)

The PORTICO clinical trial is a 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.