Back to resultsFirst in Man Study of the JenaValve TAVI Plus System Transfemoral (CP-0001)
Primary Purpose
Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
JenaValve Pericardial TAVR System
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Disease, Aortic Valve Replacement, Transcatheter, Transfemoral, Aortic Stenosis
Eligibility Criteria
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
Sites / Locations
- University of Hamburg Medical Center
- University of Koln Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcatheter Aortic Valve Replacement
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02818959
Brief Title
First in Man Study of the JenaValve TAVI Plus System Transfemoral
Acronym
CP-0001
Official Title
First in Man Study of the JenaValve TAVI Plus System Transfemoral
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to inability to recruit sufficient sample size in reasonable time frame.
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JenaValve Technology, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
Keywords
Aortic Valve Disease, Aortic Valve Replacement, Transcatheter, Transfemoral, Aortic Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcatheter Aortic Valve Replacement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
JenaValve Pericardial TAVR System
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-Cause Mortality
Description
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
Secondary Outcome Measure Information:
Title
Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints
Description
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
Other Pre-specified Outcome Measures:
Title
Device Success
Description
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
Title
Clinical Outcomes through 2-year follow-up - Hemodynamic Performance
Description
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
Title
Clinical Outcomes through 2-year follow-up - NYHA Functional Classification
Description
Number of patients with improvement over time as compared to baseline
Time Frame
Prior to discharge, at 3, 6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Baldus, MD
Organizational Affiliation
University of Koln Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hendrik Treede, MD
Organizational Affiliation
University of Hamburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hamburg Medical Center
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
University of Koln Medical Center
City
Koln
ZIP/Postal Code
50937
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
First in Man Study of the JenaValve TAVI Plus System Transfemoral
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