German TAVI-Register

Sponsor

Stiftung Institut fuer Herzinfarktforschung (Other)

Overall Status

Completed

CT.gov ID

NCT02815514

Collaborator

(none)

3,000

Enrollment

Location

Duration (Months)

31.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Valve Insufficiency

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Deutsches TAVI-Register

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Aortic valve procedures percutaneous transfemoral aortic valve implantation percutaneous transapical aortic valve implantation percutaneous transaortic aortic valve implantation aortic valve valvuloplasty surgical aortic valve replacement conservative treatment

Outcome Measures

Primary Outcome Measures

All cause mortality [5 years]

Secondary Outcome Measures

Short- and long-term results of the documented therapies [5 years]
Documentation of procedural results and clinical short-and long-term results of the documented therapies
Details on operational risk [up to four weeks]
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.
Details of performed procedures [up to four weeks]
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.
Complications during hospital stay [up to four weeks]
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.
Details of hospital stay [up to four weeks]
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.
Serious long-term complications [5 years]
Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions
Quality of life [5 years]
Drug treatment [5 years]