German TAVI-Register

Study Overview
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Brief Summary
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The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic valve treatment and the therapeutic consequences are documented.

Detailed Description
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Documentation of all consecutive patients of the participating centers with significant aortic stenosis, undergoing one of the following therapies: Percutaneous transfemoral aortic valve replacement Percutaneous aortic valve replacement transapical Percutaneous aortic valve replacement transaortic Aortic valve balloon valvuloplasty Surgical aortic valve replacement Conservative treatment Documentation of the indications, procedural results and clinical short-and long-term results of the above therapies Documentation of operational risk and quality of life Documentation of the technical implementation of the procedure and success of the intervention and of hospital reinterventions Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status) Documentation of discharge medication and the length of hospital stay Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis, the reintervention and quality of life and of drug therapy within 30 days, 1 year, 3 years and 5 years.

Official Title
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Deutsches TAVI-Register

Conditions
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Aortic Valve Stenosis, Aortic Valve Insufficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with aortic stenosis (degree III) who received one of the following therapies: transapical operative aortic valve implantation operative aortic valve implantation percutaneous aortic valve implantation balloon valvuloplasty Exclusion Criteria: missing signed informed consent
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 |
| --- | --- |
| Aortic valve procedures<br>percutaneous transfemoral aortic valve implantation percutaneous transapical aortic valve implantation percutaneous transaortic aortic valve implantation aortic valve valvuloplasty surgical aortic valve replacement conservative treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short- and long-term results of the documented therapies | Documentation of procedural results and clinical short-and long-term results of the documented therapies | 5 years | 
| Details on operational risk | Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital. | up to four weeks | 
| Details of performed procedures | Documentation of the indications, the technical implementation of the procedures and success of the intervention and of possible hospital reinterventions. Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital. | up to four weeks | 
| Complications during hospital stay | Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status). Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital. | up to four weeks | 
| Details of hospital stay | Documentation of e.g. drug treatment, discharge medication and the length of hospital stay. Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital. | up to four weeks | 
| Serious long-term complications | Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions | 5 years | 
| Quality of life |  | 5 years | 
| Drug treatment |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve stenosis, aortic valve insufficiency, transapical aortic valve implantation, aortic valve replacement, percutaneous aortic valve replacement, aortic valve valvuloplasty