German TAVI-Register

Aortic Valve Stenosis Clinical Trial

— TAVI  

Official title:

Deutsches TAVI-Register

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815514
• Other study ID #: TAVI
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: April 12, 2017
• Start date: January 2009
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 2016
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Locations

Country	Name	City	State
Germany	Institut fur Herzinfarktforschung Ludwigshafen	Ludwigshafen	RPF

Sponsors (1)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serious long-term complications	Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions	5 years
Secondary	Quality of life		5 years
Secondary	Drug treatment		5 years