CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 68 enrolled
Drug / intervention
JenaValve Pericardial TAVR 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/NCT02732691
NCT02732691N/AUnknown
CompareCT.gov

JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

JenaValve Technology, Inc.·interventional·Posted Apr 11, 2016·Updated Nov 22, 2022

In Brief

A clinical study evaluating JenaValve Pericardial TAVR System for Aortic Valve Stenosis and 4 related conditions. Targeting 68 participants across 13 sites in 4 countries.

Detailed Summary

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction
CountriesGermany, Netherlands, New Zealand, United States
Collaborators--

Timeline

N/AUnknownOverdue
20162017201820192020202120222023202420252026
First PostedApr 11, 2016
Enrollment StartOct 21, 2016
Primary CompletionMay 28, 2019
Study CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.2 years ago

Interventions

JenaValve Pericardial TAVR Systemdevice

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.