Aortic Insufficiency, Aortic Regurgitation, Aortic Stenosis
Conditions
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.
Interventions
DEVICETranscatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Sponsors
King's College London
Universitätsklinikum Hamburg-Eppendorf
JenaValve Technology, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| SF-12 Survey of Quality of Life | at 12 months | The SF-12 health survey to measure mental and physical health of the patient. |
Countries
Germany, Netherlands, Switzerland, United Kingdom
Outcome results
None listed