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

NCT ID: NCT06753227

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-28

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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AORTIC VALVE DISEASES Aortic Stenosis

Keywords

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invasive gradients haemodynamics aortic valve stenosis echocardiographic gradients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with severe aortic valve stenosis requiring transcatheter aortic valve implantation

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Joner, Professor Dr. med.

Role: STUDY_DIRECTOR

Deutsches Herzzentrum München

Locations

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Deutsches Herzzentrum München

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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Reddy YNV, Miranda WR, Nishimura RA. Measuring Pressure Gradients After Transcatheter Aortic Valve Implantation: Rethinking the Bernoulli Principle. J Am Heart Assoc. 2021 Oct 5;10(19):e022515. doi: 10.1161/JAHA.121.022515. Epub 2021 Sep 29. No abstract available.

Reference Type BACKGROUND
PMID: 34585620 (View on PubMed)

Lancellotti P, Pibarot P, Chambers J, Edvardsen T, Delgado V, Dulgheru R, Pepi M, Cosyns B, Dweck MR, Garbi M, Magne J, Nieman K, Rosenhek R, Bernard A, Lowenstein J, Vieira ML, Rabischoffsky A, Vyhmeister RH, Zhou X, Zhang Y, Zamorano JL, Habib G. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Jun;17(6):589-90. doi: 10.1093/ehjci/jew025. Epub 2016 May 3.

Reference Type BACKGROUND
PMID: 27143783 (View on PubMed)

Herrmann HC, Laskey WK. Pressure loss recovery in aortic valve stenosis: Contemporary relevance. Catheter Cardiovasc Interv. 2022 Jan 1;99(1):195-197. doi: 10.1002/ccd.29729. Epub 2021 Apr 22.

Reference Type BACKGROUND
PMID: 33886155 (View on PubMed)

Abbas AE, Mando R, Kadri A, Khalili H, Hanzel G, Shannon F, Al-Azizi K, Waggoner T, Kassas S, Pilgrim T, Okuno T, Camacho A, Selberg A, Elmariah S, Bavry A, Ternacle J, Christensen J, Gheewala N, Pibarot P, Mack M. Comparison of Transvalvular Aortic Mean Gradients Obtained by Intraprocedural Echocardiography and Invasive Measurement in Balloon and Self-Expanding Transcatheter Valves. J Am Heart Assoc. 2021 Oct 5;10(19):e021014. doi: 10.1161/JAHA.120.021014. Epub 2021 Sep 29.

Reference Type BACKGROUND
PMID: 34585593 (View on PubMed)

Abbas AE, Mando R, Hanzel G, Gallagher M, Safian R, Hanson I, Almany S, Pibarot P, Dalal P, Vivacqua A, Sakwa M, Shannon F. Invasive Versus Echocardiographic Evaluation of Transvalvular Gradients Immediately Post-Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2019 Jul;12(7):e007973. doi: 10.1161/CIRCINTERVENTIONS.119.007973. Epub 2019 Jul 5. No abstract available.

Reference Type BACKGROUND
PMID: 31272227 (View on PubMed)

Other Identifiers

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2023-456-S-SB

Identifier Type: -

Identifier Source: org_study_id