Recruiting

Doppler-Echocardiography vs. Catheterization

Sponsor:

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

Code:

NCT05459233

Conditions

Aortic Valve Stenosis

Aortic Valve Regurgitation

Prosthesis Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doppler-echocardiography

Invasive hemodynamic measurements

Study Details

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

Study ID

NCT05459233

Start date

Jan 11, 2023

Status verified date

Mar, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Doppler-echocardiography

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Josep Rodés-Cabau, MD

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

Emilie Pelletier Beaumont, MSc

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

Locations

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

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Hina Khan

hikhan@mhs.net

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Lauren Scribner

Lauren.Scribner@corewellhealth.org

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Tricia A

(507) 422-3897conley.tricia@mayo.edu

The Christ Hospital Health Network

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Susan Reilly

513-585-2165Susan.Reilly@thechristhospital.com

IUCPQ

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Josep Rodes-Cabau, MD

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

Emilie Pelletier Beaumont, MSc

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

Principal Investigator:

Josep Rodes-Cabau, MD

More Information

Sponsor

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

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval on 2026-03-24.