NCT02815514

German TAVI-Register

Deutsches TAVI-Register

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (actual)
• Sponsor: Stiftung Institut fuer Herzinfarktforschung · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Documentation of all consecutive patients of the participating centers with significant aortic stenosis, undergoing one of the following therapies: 1. Percutaneous transfemoral aortic valve replacement 2. Percutaneous aortic valve replacement transapical 3. Percutaneous aortic valve replacement transaortic 4. Aortic valve balloon valvuloplasty 5. Surgical aortic valve replacement 6. 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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-11-01
• Completion: 2016-12-01
• First posted: 2016-06-28
• Last updated: 2017-04-13

Locations

1 site across 1 country: Germany