First in Man Study of the JenaValve TAVI Plus System Transfemoral (CP-0001)

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.

Study Overview

• Status: Terminated
• Conditions: Heart Diseases; Cardiovascular Diseases; Aortic Valve Stenosis; Heart Valve Diseases
• Intervention / Treatment: Device: JenaValve Pericardial TAVR System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • University of Hamburg Medical Center
  • Koln, Germany, 50937
    • University of Koln Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Aortic Valve Replacement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: JenaValve Technology, Inc.
• Investigators: Principal Investigator: Stephan Baldus, MD, University of Koln Medical Center; Principal Investigator: Hendrik Treede, MD, University of Hamburg Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Aortic Valve Replacement; Transfemoral; Transcatheter; Aortic Valve Disease
• Additional Relevant MeSH Terms: Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Diseases; Cardiovascular Diseases; Aortic Valve Stenosis; Heart Valve Diseases
• Other Study ID Numbers: JV04FIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No