JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

JenaValve Technology, Inc.210 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

210

Conditions

Aortic Stenosis Aortic Insufficiency Aortic Regurgitation

Interventions

Transcatheter aortic valve replacementDEVICE

Transcatheter aortic valve replacement via a transapical access

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (15)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Herzzentrum der Universität

Cologne, Germany

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

Dresden, Germany

Outcomes

Primary Outcomes

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.

Time frame: 30 day

Secondary Outcomes

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

Time frame: peri- and post-operatively and at 3, 6, 12, 24 and 36 months

Device Success

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

Time frame: Index Procedure and Immediate Post-operative

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

Time frame: Prior to discharge, at 3, 6, 12, 24 and 36 months

SF-12 Survey of Quality of Life

The SF-12 health survey to measure mental and physical health of the patient.

Data from ClinicalTrials.gov

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