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REPRISE II: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Perfomance

To evaluate the safety and performance of the Lotus Valve system for transcathether aortic valve replacment (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGuard*-HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)

To demonstrate the safety and performance of the Embolic Deflection Device (TriGuard*HDH) in patients undergoing Transcatheter Aortic Valve Replacement (TAVI).

A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch System.

The objective of the study is to demonstrate the safety, feasibility and potential efficacy of using GDS Accucinch System in human subjects with heart failure and clinically significant functional mitral regurgitation.

MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study

The study is designed to clinically demonstrate device acute safety (Primary Endpoint) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).The main objectives of the study areU :1) Evaluate the Acute safety of the…

Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fraction

Primary objective: The primary objective of this non-randomized intervention trial is to investigate whether TAVR improves exercise capacity in patients with preserved LVEF and NF/LG or LF/LG severe AS reclassified based on hybrid CT/TTE-derived…