SwissTAVI Registry

Study Overview
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Brief Summary
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The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to include patients in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to five years.

Detailed Description
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The present registry aims to assess the safety and efficacy of TAVI with CE approved devices at Swiss cardiovascular centers. The Swiss Working group of Interventional Cardiology and Acute Coronary Syndrome decided to establish a nationwide registry in collaboration with the Swiss Society of Cardiac Surgery in order to assess the procedural and clinical outcome of TAVI patients. This prospective registry will help to identify candidates for TAVI, will report on peri-procedural outcome and on long-term efficacy of the devices. Last but not least it is a tool to increase quality of treatment of this high-risk patient population. Methods This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.

Official Title
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SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation

Conditions
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Aortic Valve Disease Mixed

Intervention / Treatment
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* Procedure: Transcatheter Aortic Valve Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Native aortic valve stenosis Native aortic valve regurgitation Degenerated aortic bioprosthesis requiring treatment Exclusion Criteria Patients refuses informed consent to participate in the registry Contraindication for TAVI High probability of non-adherence to the follow up - requirements
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 |
| --- | --- |
| 1<br>Patients with native aortic stenosis undergoing TAVI | Procedure: Transcatheter Aortic Valve Implantation<br>* Minimal Invasive Implantation of a biological prosthesis in Aortic Position<br>|
| 2<br>Patients with native aortic regurgitation undergoing TAVI | |
| 3<br>Patients with degenerative surgical bioprosthesis undergoing TAV-in-SAV | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by: death stroke aortic valve re-intervention structural valve deterioration myocardial Infarction | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by: death stroke aortic valve re-intervention myocardial Infarction kidney injury access related complications pacemaker requirements | 30days | 
| combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by: death stroke aortic valve re-intervention structural valve deterioration | 5 years | 
| combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by: death stroke aortic valve re-intervention structural valve deterioration | 10 years , 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VARC, Transcatheter, Minimal-invasive, TAVI, Aortic valve, Heart valve, TAVR