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NCT Number: NCT05459233

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

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,

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ, Québec, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in Quality of life (Efficacy)

    Time frame: 12 months follow-up

    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.

  2. Periprocedural complications (Safety)

    Time frame: Periprocedural

    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.

Secondary outcomes

  1. Residual transvalvular gradient

    Time frame: 1 month and 12 months follow-up

    Residual (maximal and mean) transvalvular gradient

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

    Time frame: 1 month and 12 months follow-up

    Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).

  3. Heart failure

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    Evaluated by the New York Heart Association (NYHA) Functional Classification

  4. Exercise capacity

    Time frame: 1 month and 12 months follow-up

    Exercise capacity as evaluated by the six-minute wlak test.

  5. Changes in Quality of life

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

    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.

  6. Clinical safety endpoints

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    Individually and combined: death, stroke, major of lifethreatening bleeding, pacemaker implantation, myocardial infarction

  7. re-hospitalization

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    Need for re-hospitalization

  8. wear and tear deterioration (Structural valve degeneration)

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    wear and tear evaluated by echocardiography imaging

  9. Leaflet disruption (Structural valve degeneration)

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    leaflet disruption evaluated by echocardiography imaging

  10. flail leaflet (Structural valve degeneration)

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    flail leaflet evaluated by echocardiography imaging

  11. leaflet fibrosis and/or calcification (Structural valve degeneration)

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    leaflet fibrosis and/or calcification evaluated by echocardiography imaging

  12. strut fracture or deformation (Structural valve degeneration)

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    strut fracture or deformation evaluated by echocardiography imaging

  13. Valve re-intervention

    Time frame: 1 and 12 months follow-up and yearly up to 5 years

    Need for valve re-intervention

  14. Changes in Left ventricle mass

    Time frame: 1-month and 1-year follow-up

    Changes in LV mass

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie Pelletier Beaumont, MSc

CONTACT

[email protected]

418-656-8711 ext. 3929

Josep Rodés-Cabau, MD

CONTACT

[email protected]

418-656-8711

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

Acronym: ECHOCATH

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Jul 14, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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