The Prospective Segeberg TAVI Registry (POST-TAVI)

June 3, 2022 updated by: Segeberger Kliniken GmbH

A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg

A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective single center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 years to assess valve durability.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bad Segeberg, Germany, 23795
        • Recruiting
        • Heart Center, Segeberger Kliniken
        • Contact:
          • Mohamed Abdel-Wahab, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All comers patient population treated with TAVI.

Description

Inclusion Criteria:

  • All patients treated with TAVI

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Up to 10 years
Cardiovascular and not cardiovascular death
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural valve deterioration
Time Frame: Up to 10 years
Transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Segeberger Kliniken GmbH

Investigators

  • Study Chair: Gert Richardt, MD, Heart Center, Segeberger Kliniken
  • Principal Investigator: Mohamed Abdel-Wahab, MD, Heart Center, Segeberger Kliniken

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2032

Study Registration Dates

First Submitted

June 18, 2017

First Submitted That Met QC Criteria

June 18, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK 109 -- 168/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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