NCT02815514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 13, 2017

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

March 22, 2011

Last Update Submit

April 12, 2017

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Keywords

aortic valve stenosisaortic valve insufficiencytransapical aortic valve implantationaortic valve replacementpercutaneous aortic valve replacementaortic valve valvuloplasty

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    5 years

Secondary Outcomes (8)

  • Short- and long-term results of the documented therapies

    5 years

  • Details on operational risk

    up to four weeks

  • Details of performed procedures

    up to four weeks

  • Complications during hospital stay

    up to four weeks

  • Details of hospital stay

    up to four weeks

  • +3 more secondary outcomes

Study Arms (1)

Aortic valve procedures

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • missing signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut fur Herzinfarktforschung Ludwigshafen

Ludwigshafen, RPF, 67063, Germany

Location

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jochen Senges, MD

    Stiftung Insitut fuer Herzinfarktforschung

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2011

First Posted

June 28, 2016

Study Start

January 1, 2009

Primary Completion

November 1, 2011

Study Completion

December 1, 2016

Last Updated

April 13, 2017

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)