JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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The JenaValve EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency

Conditions
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Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation

Intervention / Treatment
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* Device: Transcatheter aortic valve replacement


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk patients with aortic stenosis<br>Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis. | Device: Transcatheter aortic valve replacement<br>* Transcatheter aortic valve replacement via a transapical access<br>* Other names: The JenaValve TAVI System;|
| High risk patients with AI<br>Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation. | Device: Transcatheter aortic valve replacement<br>* Transcatheter aortic valve replacement via a transapical access<br>* Other names: The JenaValve TAVI System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| SF-12 Survey of Quality of Life | The SF-12 health survey to measure mental and physical health of the patient. | at 12 months | 
| 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 | 
| 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 |