German TAVI-Register

Stiftung Institut fuer Herzinfarktforschung3,000 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Aortic Valve Stenosis Aortic Valve Insufficiency

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Institut fur Herzinfarktforschung Ludwigshafen

Ludwigshafen, RPF, Germany

Outcomes

Primary Outcomes

All cause mortality

Time frame: 5 years

Secondary Outcomes

Short- and long-term results of the documented therapies

Documentation of procedural results and clinical short-and long-term results of the documented therapies

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: up to four weeks

Data from ClinicalTrials.gov

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