Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart Valves. (IVEGA-TAVI)

December 22, 2024 updated by: Deutsches Herzzentrum Muenchen

Systematic Assessment of Invasive Versus Echocardiography-derived Transprosthetic Gradients After Transcatheter Aortic Valve Implantation Using Balloon-expandable Transcatheter Heart Valves: the IVEGA-TAVI Study.

The aim of this prospective registry is to compare invasive versus echocardiography-derived transvalvular gradients before and after TAVI with balloon-expandable THVs.All patients will undergo a transthoracic echocardiogram in the operating room prior to aortic valve implantation. In addition, two catheters (one in the ventricle and one in the aorta) will be used to invasively measure the transvalvular gradient both before and after aortic valve implantation. The invasive measurements will be performed in different positions of the ventricle and aorta simultaneously. At the end of the procedure, aortic gradient measurement by echocardiography shall be performed again. A maximal three months follow-up is expected.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

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

Study Locations

  • Germany
    • Bayern
      • Munich, Bayern, Germany, 80636
        • Deutsches Herzzentrum München

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All consecutive patients with severe aortic valve stenosis undergoing TAVI with balloon-expandable transcatheter heart valves (THV).

Description

Inclusion Criteria:

  • Age ≥ 18 years and able to give consent
  • Severe symptomatic native aortic valve stenosis with indication for TAVI according to 2021 ESC/EACTS Valvular Heart Disease Guidelines.
  • Use of balloon-expandable THV
  • Written informed consent

Exclusion Criteria:

  • Emergency or urgent treatment indication
  • Patients under hemodynamically unstable conditions.
  • Previous bioprosthetic aortic valve implantation
  • Patient cannot adhere to or complete the trial protocol for any reason

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

Cohorts and Interventions

Group / Cohort
Patients with severe aortic valve stenosis requiring transcatheter aortic valve implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient after TAVI.
Time Frame: From enrollment to 3 months
From enrollment to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient before TAVI.
Time Frame: From enrollment to 3 months
From enrollment to 3 months
To compare pulse-wave Doppler above the aortic valve before and after TAVI
Time Frame: From enrollment to 3 months
From enrollment to 3 months
To compare pre-ejection period time pre and post TAVI.
Time Frame: From enrollment to 3 months
From enrollment to 3 months

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Edwards Lifesciences

Investigators

  • Study Director: Michael Joner, Professor Dr. med., Deutsches Herzzentrum München

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)

May 28, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 22, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-456-S-SB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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