First in Man Study of the JenaValve TAVI Plus System Transfemoral

Cardiovascular Diseases Clinical Trial

— CP-0001  

Official title:

First in Man Study of the JenaValve TAVI Plus System Transfemoral

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02818959
• Other study ID #: JV04FIM
• Status: Terminated
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2020
• Source: JenaValve Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with severe native aortic valve stenosis

• NYHA functional class II or higher

• Increased risk for surgical aortic valve replacement

• Comply with post-operative follow-up visits and requirements

Exclusion Criteria:

• Combined aortic valve disease with severe aortic insufficiency

• Presence of moderate mitral insufficiency or previous mitral prosthesis

• Severe pulmonary hypertension

• Congenital uni- or bicuspid aortic valve

• Endocarditis or active infection

• Life expectancy < 12 months

• Need for emergency surgery for any reason

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiovascular Diseases
• Heart Diseases
• Heart Valve Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Hamburg Medical Center	Hamburg
Germany	University of Koln Medical Center	Koln

Sponsors (1)

Lead Sponsor	Collaborator
JenaValve Technology, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Index Procedure and Immediate Post-operative
Other	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	Prior to discharge, at 3, 6, 12 and 24 months
Other	Clinical Outcomes through 2-year follow-up - NYHA Functional Classification	Number of patients with improvement over time as compared to baseline	Prior to discharge, at 3, 6, 12 and 24 months
Primary	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.	30 days
Secondary	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	Index Procedure and Immediate Post-operative