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

Part of paid clinical trials in San Francisco, California.

Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study ID
NCT05459233
Status
Recruiting
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Conditions

  • Aortic Valve Regurgitation
  • Aortic Valve Stenosis
  • Prosthesis Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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,

Key Dates

Start date
Jan 11, 2023
Status verified
Mar 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2029

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Doppler-echocardiography
    Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.
  • Other: Invasive hemodynamic measurements
    Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).

Primary Outcome Measure

Changes in Quality of life (Efficacy) [ Time Frame: 12 months follow-up ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94143
Sammy Elmariah
Mallika Saxena
[email protected]
South Broward Hospital Disctrict D/B/A Memorial Healthcare SystemHollywoodFlorida33021
Houman Khalili
Hina Khan
[email protected]
William Beaumont HospitalRoyal OakMichigan48073
Amr Abbas
Lauren Scribner
[email protected]
Mayo ClinicRochesterMinnesota55905
Mackram F Eleid, M.D.
Tricia A
[email protected]
(507) 422-3897
St-Joseph's Health INCSyracuseNew York13203
Ayman Iskander
Laura Mowers
[email protected]
The Christ Hospital Health NetworkCincinnatiOhio45219
Santiago Garcia, M.D.
Susan Reilly
[email protected]
513-585-2165

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By research site
University of California· San Francisco, CASouth Broward Hospital Disctrict D/B/A Memorial Healthcare System· Hollywood, FLWilliam Beaumont Hospital· Royal Oak, MIMayo Clinic· Rochester, MNSt-Joseph's Health INC· Syracuse, NYThe Christ Hospital Health Network· Cincinnati, OH

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