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Compares treatment options for Aortic Valve Stenosis
Official title Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
ClinicalTrials.gov ID: NCT05459233
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve...
- Surgical stented bioprosthetic valve (label size ≤25 mm)
- TAVR with the SAPIEN 3 Ultra valve
You likely can't join if
- 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...
- Impossibility to obtain written informed consent
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Hollywood, Florida, United States
- Royal Oak, Michigan, United States
- Rochester, Minnesota, United States
- Syracuse, New York, United States
- Cincinnati, Ohio, United States
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Hollywood, Florida, United States; Royal Oak, Michigan, United States; Rochester, Minnesota, United States; Syracuse, New York, United States; Cincinnati, Ohio, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.