An interventional study of JenaValve Pericardial TAVR System in Aortic Valve Stenosis, Heart Valve Diseases and Heart Diseases, sponsored by JenaValve Technology, Inc.. Terminated at 2 sites in Germany. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by JenaValve Technology, Inc. · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.
The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the "Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2)". These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 7 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
In this study, transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial TAVR System, which is intended for use in subjects with severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using a delivery system.
Device: JenaValve Pericardial TAVR System
The JenaValve Pericardial TAVI system is intended for use in subjects with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement.
All-Cause Mortality
30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve Plus Prosthesis irrespective of the underlying cause of death.
Time frame: 30 days
Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints
* Myocardial Infarction * Stroke * Major Bleeding * Acute Kidney Injury * Vascular Complications * Conduction Disturbances and Arrhythmias * TAVR-related Complications
Time frame: Index Procedure and Immediate Post-operative
Device Success
Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve
Time frame: Index Procedure and Immediate Post-operative
Clinical Outcomes through 2-year follow-up - Hemodynamic Performance
Improvement in mean gradient and effective orifice area compared to baseline and over time as assessed by Echocardiogram
Time frame: Prior to discharge, at 3, 6, 12 and 24 months
Clinical Outcomes through 2-year follow-up - NYHA Functional Classification
Number of patients with improvement over time as compared to baseline
Time frame: Prior to discharge, at 3, 6, 12 and 24 months
Plan to share: No
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This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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JenaValve Technology, Inc.