Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

NCT05459233 | Recruiting

• 1 other identifier: ECHOCATH
• Study Type: interventional
• Target: 310
• Locations: 2 countries
• Sites: 7

Brief Summary

Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,

Conditions

Aortic Valve Stenosis; Aortic Valve Regurgitation; Prosthesis Failure

Outcome Measures

Primary Outcomes (2)

• Changes in Quality of life (Efficacy)

  Change in quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). All score are represented on a 0-to-100-point scale (lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life).The KCCQ is a 7 domains questionnaire; symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy.

  12 months follow-up

• Periprocedural complications (Safety)

  Periprocedural complications including in-hospital mortality, stroke, annular rupture, coronary obstruction, new-onset left bundle branch block, need for permanent pacemaker implantation and conversion to open heart surgery.

  Periprocedural

Secondary Outcomes (14)

• Residual transvalvular gradient

  1 month and 12 months follow-up

• Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance)

  1 month and 12 months follow-up

• Heart failure

  1 and 12 months follow-up and yearly up to 5 years

• Exercise capacity

  1 month and 12 months follow-up

• Changes in Quality of life

  after 1-year follow-up (yearly up to 5 years)

Study Arms (2)

Doppler-echocardiography

OTHER

Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.

Procedure: Doppler-echocardiography

Invasive hemodynamic measurements

OTHER

Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).

Procedure: Invasive hemodynamic measurements

Interventions

Doppler-echocardiography PROCEDURE

The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Balloon post-dilation with a non-compliant balloon will be performed in the presence of a residual mean gradient ≥20 mmHg as assessed by Doppler-echocardiography.

Doppler-echocardiography

Invasive hemodynamic measurements PROCEDURE

The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording). Balloon post-dilation will be performed with a non-compliant balloon in the presence of a mean residual gradient ≥20 mmHg as assessed by hemodynamic measurements.

Invasive hemodynamic measurements

Eligibility Criteria

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

You may qualify if:

• Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team
• Surgical stented bioprosthetic valve (label size ≤25 mm)
• TAVR with the SAPIEN 3 Ultra valve

You may not qualify if:

• Stentless or sutureless surgical valves
• Trifecta bioprosthesis
• Hancock II bioprosthesis
• High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \<4 mm or based on the criterion of the heart team responsible for the procedure).
• Impossibility to obtain written informed consent

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: lead

Study Sites (7)

University of California

San Francisco, California, 94143, United States

NOT YET RECRUITING

South Broward Hospital Disctrict D/B/A Memorial Healthcare System

Hollywood, Florida, 33021, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

St-Joseph's Health INC

Syracuse, New York, 13203, United States

NOT YET RECRUITING

The Christ Hospital Health Network

Cincinnati, Ohio, 45219, United States

RECRUITING

IUCPQ

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (10)

• Paradis JM, Del Trigo M, Puri R, Rodes-Cabau J. Transcatheter Valve-in-Valve and Valve-in-Ring for Treating Aortic and Mitral Surgical Prosthetic Dysfunction. J Am Coll Cardiol. 2015 Nov 3;66(18):2019-2037. doi: 10.1016/j.jacc.2015.09.015.

  PMID: 26516006 BACKGROUND

• VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.

  PMID: 33888385 BACKGROUND

• Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, Barbanti M, Latib A, Schaefer U, Rodes-Cabau J, Treede H, Piazza N, Hildick-Smith D, Himbert D, Walther T, Hengstenberg C, Nissen H, Bekeredjian R, Presbitero P, Ferrari E, Segev A, de Weger A, Windecker S, Moat NE, Napodano M, Wilbring M, Cerillo AG, Brecker S, Tchetche D, Lefevre T, De Marco F, Fiorina C, Petronio AS, Teles RC, Testa L, Laborde JC, Leon MB, Kornowski R; Valve-in-Valve International Data Registry Investigators. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. 2014 Jul;312(2):162-70. doi: 10.1001/jama.2014.7246.

  PMID: 25005653 BACKGROUND

• Bleiziffer S, Simonato M, Webb JG, Rodes-Cabau J, Pibarot P, Kornowski R, Windecker S, Erlebach M, Duncan A, Seiffert M, Unbehaun A, Frerker C, Conzelmann L, Wijeysundera H, Kim WK, Montorfano M, Latib A, Tchetche D, Allali A, Abdel-Wahab M, Orvin K, Stortecky S, Nissen H, Holzamer A, Urena M, Testa L, Agrifoglio M, Whisenant B, Sathananthan J, Napodano M, Landi A, Fiorina C, Zittermann A, Veulemans V, Sinning JM, Saia F, Brecker S, Presbitero P, De Backer O, Sondergaard L, Bruschi G, Franco LN, Petronio AS, Barbanti M, Cerillo A, Spargias K, Schofer J, Cohen M, Munoz-Garcia A, Finkelstein A, Adam M, Serra V, Teles RC, Champagnac D, Iadanza A, Chodor P, Eggebrecht H, Welsh R, Caixeta A, Salizzoni S, Dager A, Auffret V, Cheema A, Ubben T, Ancona M, Rudolph T, Gummert J, Tseng E, Noble S, Bunc M, Roberts D, Kass M, Gupta A, Leon MB, Dvir D. Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves. Eur Heart J. 2020 Aug 1;41(29):2731-2742. doi: 10.1093/eurheartj/ehaa544.

  PMID: 32592401 BACKGROUND

• de Freitas Campos Guimaraes L, Urena M, Wijeysundera HC, Munoz-Garcia A, Serra V, Benitez LM, Auffret V, Cheema AN, Amat-Santos IJ, Fisher Q, Himbert D, Garcia Del Blanco B, Dager A, Le Breton H, Paradis JM, Dumont E, Pibarot P, Rodes-Cabau J. Long-Term Outcomes After Transcatheter Aortic Valve-in-Valve Replacement. Circ Cardiovasc Interv. 2018 Sep;11(9):e007038. doi: 10.1161/CIRCINTERVENTIONS.118.007038.

  PMID: 30354588 BACKGROUND

• Wernly B, Zappe AK, Unbehaun A, Sinning JM, Jung C, Kim WK, Fichtlscherer S, Lichtenauer M, Hoppe UC, Alushi B, Beckhoff F, Wewetzer C, Franz M, Kretzschmar D, Navarese E, Landmesser U, Falk V, Lauten A. Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves. Clin Res Cardiol. 2019 Jan;108(1):83-92. doi: 10.1007/s00392-018-1326-z. Epub 2018 Jul 12.

  PMID: 30003366 BACKGROUND

• Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483.

  PMID: 31146808 BACKGROUND

• Kaneko T, Makkar RR, Krishnaswami A, Hermiller J, Greenbaum A, Babaliaros V, Shah PB, Bailey SH, Bapat V, Kapadia S, Abbas AE. Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality. Circ Cardiovasc Interv. 2021 May;14(5):e010288. doi: 10.1161/CIRCINTERVENTIONS.120.010288. Epub 2021 May 18.

  PMID: 34003666 BACKGROUND

• Saxon JT, Allen KB, Cohen DJ, Chhatriwalla AK. Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside. Interv Cardiol. 2018 Jan;13(1):20-26. doi: 10.15420/icr.2017:29:1.

  PMID: 29593832 BACKGROUND

• O'Donnell JP, O'Sullivan CJ. Bioprosthetic Aortic Valve Fracture During Valve-in-valve Transcatheter Aortic Valve Implantation. Interv Cardiol. 2019 Nov 18;14(3):147-151. doi: 10.15420/icr.2019.08.R2. eCollection 2019 Nov.

  PMID: 31867060 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Prosthesis Failure

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josep Rodés-Cabau, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Rodés-Cabau, MD

CONTACT

418-656-8711; josep.rodes@criucpq.ulaval.ca

Emilie Pelletier Beaumont, MSc

CONTACT

418-656-8711; emilie.pelletier-beaumont@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will be randomized in a 1:1 fashion to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 14, 2022
• Study Start: January 11, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (6); CA (1)