Clinical trial NCT05459233: Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Official title: Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Regurgitation
Prosthesis Failure
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 fashion to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.
Primary purpose: TREATMENT

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,

Detailed description: This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Quality of life (Efficacy)
timeFrame: 12 months follow-up
measure: Periprocedural complications (Safety)
timeFrame: Periprocedural
Secondary outcomes:
measure: Residual transvalvular gradient
timeFrame: 1 month and 12 months follow-up
measure: Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance)
timeFrame: 1 month and 12 months follow-up
measure: Heart failure
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: Exercise capacity
timeFrame: 1 month and 12 months follow-up
measure: Changes in Quality of life
timeFrame: after 1-year follow-up (yearly up to 5 years)
measure: Clinical safety endpoints
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: re-hospitalization
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: wear and tear deterioration (Structural valve degeneration)
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: Leaflet disruption (Structural valve degeneration)
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: flail leaflet (Structural valve degeneration)
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: leaflet fibrosis and/or calcification (Structural valve degeneration)
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: strut fracture or deformation (Structural valve degeneration)
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: Valve re-intervention
timeFrame: 1 and 12 months follow-up and yearly up to 5 years
measure: Changes in Left ventricle mass
timeFrame: 1-month and 1-year follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Hollywood
country: United States
facility: South Broward Hospital Disctrict D/B/A Memorial Healthcare System
state: Florida
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Syracuse
country: United States
facility: St-Joseph's Health INC
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital Health Network
state: Ohio
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Josep Rodés-Cabau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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