First in Man Study of the JenaValve TAVI Plus System Transfemoral

NCT02818959 | Terminated

• 1 other identifier: JV04FIM
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Keywords

Aortic Valve Disease; Aortic Valve Replacement; Transcatheter; Transfemoral; Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints

  Index Procedure and Immediate Post-operative

Other Outcomes (3)

• Device Success

  Index Procedure and Immediate Post-operative

• Clinical Outcomes through 2-year follow-up - Hemodynamic Performance

  Prior to discharge, at 3, 6, 12 and 24 months

• Clinical Outcomes through 2-year follow-up - NYHA Functional Classification

  Prior to discharge, at 3, 6, 12 and 24 months

Study Arms (1)

Transcatheter Aortic Valve Replacement

EXPERIMENTAL

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

Interventions

JenaValve Pericardial TAVR System DEVICE

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.

Transcatheter Aortic Valve Replacement

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JenaValve Technology, Inc.: lead

Study Sites (2)

University of Koln Medical Center

Cologne, 50937, Germany

Location

University of Hamburg Medical Center

Hamburg, 20251, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Ventricular Outflow Obstruction

Study Officials

• Stephan Baldus, MD

  University of Koln Medical Center

  PRINCIPAL INVESTIGATOR

• Hendrik Treede, MD

  University of Hamburg Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 30, 2016
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)