Everyday Practice With Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.

Detailed Description
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The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.

Official Title
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Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: aortic valve prostheses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic stenosis Intermediate-to-high risk for surgery Heart team decision Exclusion Criteria: Contraindication to transfemoral TAVI procedure
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 |
| --- | --- |
| TAVI patients<br>all patients undergoing transcatheter aortic valve prostheses implantation | Device: aortic valve prostheses<br>* balloon-expandable and self-expandable aortic valve prostheses<br>* Other names: CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post-TAVI aortic regurgitation | echocardiographicall and angiographycally determined | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of bleeding complications | defined according to BARC and VARC-2 classification | 30 days | 
| mortality | all-cause and cardio/cerebrovascular death | 30 days | 
| mortality rate | all-cause and cardio/cerebrovascular death | 2-years | 
| mortality rate | all-cause and cardio/cerebrovascular death | 5-years | 
| incidence of cerebrovascular events | stroke or TIA | 30 days | 
| incidence of cerebrovascular events | stroke or TIA | 2-years | 
| incidence of cerebrovascular events | stroke or TIA | 5-years | 
| incidence of new pacemaker implantation | pacemaker after TAVI | 30-day | 
| incidence of new pacemaker implantation | pacemaker after TAVI | 1-year |