German TAVI-Register (TAVI)

Deutsches TAVI-Register

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

Study Overview

• Status: Completed
• Conditions: 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:

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 (Actual): 3000

Contacts and Locations

Study Locations

• Germany
  • RPF
    • Ludwigshafen, RPF, Germany, 67063
      • Institut fur Herzinfarktforschung Ludwigshafen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with significant aortic valve stenosis, treated with aortic valve procedures.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life		5 years
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
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
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
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
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
Serious long-term complications	Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions	5 years
Drug treatment		5 years

Collaborators and Investigators

• Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Investigators: Principal Investigator: Jochen Senges, MD, Stiftung Insitut fuer Herzinfarktforschung

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (ESTIMATE): June 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: aortic valve replacement; aortic valve stenosis; aortic valve insufficiency; transapical aortic valve implantation; percutaneous aortic valve replacement; aortic valve valvuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO