A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)

Date Added
December 14th, 2021
PRO Number
Pro00116082
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Early Feasibility Study of the Edwards SAPIEN 3 System with the Edwards Caval Prestent for the Treatment of Reverse Caval Flow

Date Added
November 9th, 2021
PRO Number
Pro00116089
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate if the Edwards SAPIEN 3 System with Edwards Caval Prestent (study device) can help treat patients with your symptoms (symptomatic heart failure patients with signs of excessive fluid retention) resulting from reverse caval flow (blood flowing backwards instead of forward to your lungs).

The type of research study you are being asked to join is called an Early Feasibility Study. Prior clinical studies have not been conducted for the study device and its safety and effectiveness are unknown. This means the study Device you are receiving has not been previously studied in humans, and that you will be among the first subjects in the world to undergo this treatment. The study device is considered investigational and not approved for commercial sale by the US Food and Drug Administration (FDA). The study device will be placed in the section of your inferior vena cava (IVC) (the major vein that brings oxygen-poor blood from the lower body back to the heart) below your heart and above the veins in your liver via a vein in your thigh.

The clinical benefits of using the study device for treatment of your condition is not well known at this time. Some possible benefits that may occur from use of the study device may include:
relief of symptoms related to heart failure including but limited to, improved fluid retention,
quality of life, and/or improvement in morbidity (illness or disease) and mortality (death).

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu



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