RightFit
RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to check how well a new heart valve works: heart ultrasound and measurements taken through a thin tube called a catheter. It is for people getting a new valve placed inside a failing tissue aortic valve that was put in during surgery.

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,

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your tissue aortic valve from past surgery is severely narrowed, leaking badly, or both. Your heart care team has approved placing a new valve inside it.
  • Your surgical tissue valve has a support frame and a labeled size of 25 millimeters or less.
  • Your new valve will be a SAPIEN 3 Ultra valve.

Who can't join

  • Your surgical valve has no support frame or was designed to be placed without stitches.
  • You have a Trifecta tissue valve.
  • You have a Hancock II tissue valve.
  • You have a high risk of blocking an artery that supplies blood to the heart. This means a CT scan shows less than 4 millimeters between the planned valve and the artery, or your heart care team judges the risk to be high.
  • Written consent to join the study cannot be obtained.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (6)

CA

FL

MI

MN

NY

OH