Clin2
NCT05261204Possibly a fitActive, not recruiting

TAVR vs surgery for narrowed aortic valve

Prosthesis SurvivalProsthesis; Cardiac, Heart, Functional Disturbance as Result

Part of Heart & circulation clinical trials.

This trial compares a less invasive valve procedure called TAVR with standard open-heart surgery to replace a narrowed aortic valve. It studies which approach works best for people who are considered higher risk for surgery.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
4,000 people
Ages
18 years to 90 years
Study type
Observational

Who can take part

  • You have a narrowed aortic valve causing symptoms and test abnormalities (such as mean gradient over 40, or jet speed over 4.0 m/s, or valve area under 0.8 cm²).
  • You are considered high risk for surgical valve replacement (predicted risk of death from surgery about 15% or higher, or a STS score 10 or higher).
  • If your STS score is below 10, two surgeons must review your case and agree your predicted surgical risk is still 15% or higher.
  • You have no recent heart attack in the past month before the planned treatment.
  • You are medically stable enough for the procedure (no severe instability needing strong “push” medicines or a heart machine).
  • You can take required blood-thinning medicines like aspirin and heparin, and contrast dye if needed (with no serious allergy that can’t be prevented).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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