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

Status: Recruiting

This study investigates the optimization of how blood flows through heart valve replacements after a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure. It compares two methods used to measure valve performance: heart ultrasound and catheter-based pressure measurements. Patients are randomly assigned to have their treatment guided by one of these methods. Researchers will evaluate which approach leads to better valve function, quality of life, and safety outcomes.

I'm interested

Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:
Surgical aortic bioprosthetic valve failure with severe aortic stenosis/regurgitation Approved for valve-in-valve procedure by Heart Team Surgical stented bioprosthetic valve (size ?25 mm) Transcatheter aortic valve replacement with SAPIEN 3 Ultra valve
Exclusion Criteria:
Stentless or sutureless surgical valves Trifecta or Hancock II bioprosthesis Significant chance that the heart procedure could block one of the arteries that supplies blood to the heart muscle. Unable to provide consent
Interventions:

Drug/Device: TAVR

Conditions:

Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure

Keywords:

Surgical aortic bioprosthetic valve dysfunction, Valve in Valve TAVR

Contact(s): Darla Washington - dawashi19@hfhs.org
Principal Investigator: Pedro Villablanca
Principal Investigator ID: pvillab1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov

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