German TAVI-Register

Institute for Heart Attack Research Foundation (IHF)

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT02815514

TAVI

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Aortic valve procedures

Description:

1. percutaneous transfemoral aortic valve implantation 2. percutaneous transapical aortic valve implantation 3. percutaneous transaortic aortic valve implantation 4. aortic valve valvuloplasty 5. surgical aortic valve replacement 6. conservative treatment