CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 180 enrolled
Drug / intervention
JenaValve Trilogy Heart Valve Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04415047
NCT04415047N/AActive
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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)

JenaValve Technology, Inc.·interventional·Posted Jun 4, 2020·Updated Sep 13, 2022

In Brief

A clinical study evaluating JenaValve Trilogy Heart Valve System for Aortic Regurgitation and 3 related conditions. Active but no longer recruiting, targeting 180 participants across 30 sites.

Detailed Summary

To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
CountriesUnited States
Collaborators--

Timeline

N/AActive
20212022202320242025202620272028
First PostedJun 4, 2020
Enrollment StartMay 22, 2020
Primary CompletionAug 29, 2023
Study CompletionAug 1, 2028
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.1 years ago

Interventions

JenaValve Trilogy Heart Valve Systemdevice

TAVR with JenaValve Trilogy Heart Valve System