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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818959
Recruitment Status : Terminated (Due to inability to recruit sufficient sample size in reasonable time frame.)
First Posted : June 30, 2016
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology, Inc.

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Device: JenaValve Pericardial TAVR System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Man Study of the JenaValve TAVI Plus System Transfemoral
Study Start Date : December 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 30 days ]
    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 :
  1. Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints [ Time Frame: Index Procedure and Immediate Post-operative ]
    • Myocardial Infarction
    • Stroke
    • Major Bleeding
    • Acute Kidney Injury
    • Vascular Complications
    • Conduction Disturbances and Arrhythmias
    • TAVR-related Complications


Other Outcome Measures:
  1. Device Success [ Time Frame: Index Procedure and Immediate Post-operative ]
    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

  2. Clinical Outcomes through 2-year follow-up - Hemodynamic Performance [ Time Frame: Prior to discharge, at 3, 6, 12 and 24 months ]
    Improvement in mean gradient and effective orifice area compared to baseline and over time as assessed by Echocardiogram

  3. Clinical Outcomes through 2-year follow-up - NYHA Functional Classification [ Time Frame: Prior to discharge, at 3, 6, 12 and 24 months ]
    Number of patients with improvement over time as compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818959


Locations
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Germany
University of Hamburg Medical Center
Hamburg, Germany, 20251
University of Koln Medical Center
Koln, Germany, 50937
Sponsors and Collaborators
JenaValve Technology, Inc.
Investigators
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Principal Investigator: Stephan Baldus, MD University of Koln Medical Center
Principal Investigator: Hendrik Treede, MD University of Hamburg Medical Center
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Responsible Party: JenaValve Technology, Inc.
ClinicalTrials.gov Identifier: NCT02818959    
Other Study ID Numbers: JV04FIM
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by JenaValve Technology, Inc.:
Aortic Valve Disease
Aortic Valve Replacement
Transcatheter
Transfemoral
Aortic Stenosis
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Heart Valve Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction