JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

Completed

• Conditions: Aortic Stenosis; Aortic Regurgitation; Aortic Insufficiency
• Interventions: Device: Transcatheter aortic valve replacement

• Registration Number: NCT01598844
• Lead Sponsor: JenaValve Technology, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-15
• Study Start: 2012-05-30
• Primary Completion: 2015-08-27
• Study Completion: 2018-07-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-22
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk patients with AI	Transcatheter aortic valve replacement	Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation.
High risk patients with aortic stenosis	Transcatheter aortic valve replacement	Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	30 day	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.

Secondary Outcome Measures

Name	Time	Method
Device Success	Index Procedure and Immediate Post-operative	The following parameters will be collected to assess device success: 1. Successful vascular access, delivery and deployment of the device successful retrieval of the device; 2. Correct position of the device in the proper anatomical location; 3. Intended performance of the prosthetic heart valve: 4. Only one valve implanted in proper anatomical position
SF-12 Survey of Quality of Life	at 12 months	The SF-12 health survey to measure mental and physical health of the patient.
Device Effectiveness	Prior to discharge, at 3, 6, 12, 24 and 36 months	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
Safety Endpoints	peri- and post-operatively and at 3, 6, 12, 24 and 36 months	* 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
Combined Safety Endpoint	at 30 days	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
Combined Efficacy Endpoint	at 12 months	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

Trial Locations

Locations (15)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden; 🇩🇪 Dresden, Germany

University Hospital; 🇩🇪 Erlangen, Germany

Asklepios Klinik; 🇩🇪 Hamburg, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

University Heart Centre; 🇩🇪 Freiburg, Germany

Herzzentrum Leipzig - Universitätsklinik; 🇩🇪 Leipzig, Germany

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany

Herz- und Kreislaufzentrum Rotenburg (Fulda); 🇩🇪 Rotenburg An Der Fulda, Germany

Herzzentrum der Universität; 🇩🇪 Köln, Germany

Herzzentrum des Städtischen Klinikums München; 🇩🇪 Munich, Germany

Robert Bosch Krankenhaus Stuttgart; 🇩🇪 Stuttgart, Germany

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

King's College Hospital; 🇬🇧 London, United Kingdom