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

NCT06753227 | Enrolling By Invitation DMC

• 1 other identifier: 2023-456-S-SB
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AORTIC VALVE DISEASES; Aortic Stenosis

Keywords

invasive gradients; haemodynamics; aortic valve stenosis; echocardiographic gradients

Outcome Measures

Primary Outcomes (1)

• To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient after TAVI.

  From enrollment to 3 months

Secondary Outcomes (3)

• To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient before TAVI.

  From enrollment to 3 months

• To compare pulse-wave Doppler above the aortic valve before and after TAVI

  From enrollment to 3 months

• To compare pre-ejection period time pre and post TAVI.

  From enrollment to 3 months

Study Arms (1)

Patients with severe aortic valve stenosis requiring transcatheter aortic valve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

Related Publications (5)

• 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.

  PMID: 34585620 BACKGROUND

• 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.

  PMID: 27143783 BACKGROUND

• 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.

  PMID: 33886155 BACKGROUND

• 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.

  PMID: 34585593 BACKGROUND

• 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.

  PMID: 31272227 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Michael Joner, Professor Dr. med.

  Deutsches Herzzentrum München

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: May 28, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

DE (1)