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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01598844
Other study ID # JV03PMS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2012
Est. completion date July 31, 2018

Study information

Verified date November 2020
Source JenaValve Technology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.


Description:

The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement. The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date July 31, 2018
Est. primary completion date August 27, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients suitable for TAVI with the JenaValve according to instructions for use Exclusion Criteria: - Patients unsuitable for TAVI with the JenaValve according to instructions for use

Study Design


Intervention

Device:
Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access

Locations

Country Name City State
Germany Herz- und Diabeteszentrum NRW Bad Oeynhausen
Germany Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden Dresden
Germany University Hospital Erlangen
Germany University Heart Centre Freiburg
Germany Asklepios Klinik Hamburg
Germany Universitäres Herzzentrum Hamburg Hamburg
Germany Herzzentrum der Universität Köln
Germany Herzzentrum Leipzig - Universitätsklinik Leipzig
Germany Deutsches Herzzentrum München Munich
Germany Herzzentrum des Städtischen Klinikums München Munich
Germany Herz- und Kreislaufzentrum Rotenburg (Fulda) Rotenburg An Der Fulda
Germany Robert Bosch Krankenhaus Stuttgart Stuttgart
Netherlands St. Antonius Ziekenhuis Nieuwegein
Switzerland Universitätsspital Basel Basel
United Kingdom King's College Hospital London

Sponsors (3)

Lead Sponsor Collaborator
JenaValve Technology, Inc. King's College London, Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland,  United Kingdom, 

References & Publications (4)

Mieres J, Menéndez M, Fernández-Pereira C, Rubio M, Rodríguez AE. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk. Case Rep Cardiol. 2015;2015:458151. doi: 10.1155/2015/458151. Epub 2015 Aug 4. — View Citation

Seiffert M, Bader R, Kappert U, Rastan A, Krapf S, Bleiziffer S, Hofmann S, Arnold M, Kallenbach K, Conradi L, Schlingloff F, Wilbring M, Schäfer U, Diemert P, Treede H. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13. — View Citation

Silaschi M, Conradi L, Wendler O, Schlingloff F, Kappert U, Rastan AJ, Baumbach H, Holzhey D, Eichinger W, Bader R, Treede H. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart va — View Citation

Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Rüter F, de Kroon TL, Lange R, Ensminger S, Wendler O. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality 30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve prosthesis irrespective of the underlying cause of death. 30 day
Secondary Safety Endpoints All-cause mortality
Cardiovascular mortality
Major stroke
Life-threatening or disabling bleeding
Major bleeding
Acute kidney injury
Myocardial infarction
Major vascular complication
Mechanical coronary obstruction
Prosthetic valve thrombus
Prosthetic valve endocarditis
Conduction disturbance and cardiac arrhythmia
Necessity of permanent pacemaker implantation
peri- and post-operatively and at 3, 6, 12, 24 and 36 months
Secondary Device Success The following parameters will be collected to assess device success:
Successful vascular access, delivery and deployment of the device successful retrieval of the device
Correct position of the device in the proper anatomical location
Intended performance of the prosthetic heart valve:
Only one valve implanted in proper anatomical position
Index Procedure and Immediate Post-operative
Secondary Device Effectiveness The following parameters will assess effectiveness:
Transvalvular aortic peak pressure gradient
Transvalvular aortic mean pressure gradient
Effective aortic valve area
Paravalvular regurgitation coded according to VARC
Transvalvular regurgitation coded according to VARC
No clinically significant valve migration/dislocation
Absence of mechanical coronary obstruction
Functional improvement assessment by NYHA functional classification
Prior to discharge, at 3, 6, 12, 24 and 36 months
Secondary SF-12 Survey of Quality of Life The SF-12 health survey to measure mental and physical health of the patient. at 12 months
Secondary Combined Safety Endpoint A combined safety endpoint will be assessed at 30 days consisting of the following variables:
All-cause mortality
Major stroke
Acute kidney injury (Stage 3)
Life-threatening or disabling bleeding
Major vascular complication
Peri-procedural myocardial infarction
Repeat surgical or interventional procedure for valve-related dysfunction
at 30 days
Secondary Combined Efficacy Endpoint A combined efficacy endpoint will be assessed consisting of the following variables:
All-cause mortality (after > 30 days)
Failure of current therapy for AS, requiring hospitalization for symptoms of valve-related or cardiac decompensation
Prosthetic heart valve dysfunction
at 12 months
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