EARLY TAVR
Asymptomatic Aortic Stenosis
Early TAVR - Transcatheter aortic valve replacement vs OMM (randomized) for asymptomatic severe AS The EARLY TAVR trial (Edwards) looks at transcatheter aortic valve replacement (TAVR) as an effective treatment for patients with asymptomatic aortic stenosis. Patients are randomized to either treatment with TAVR or clinical surveillance until the develop symptoms, at which point they are eligible to be treated with TAVR.
https://clinicaltrials.gov/ct2/show/NCT03042104
Early TAVR - Transcatheter aortic valve replacement vs OMM (randomized) for asymptomatic severe AS The EARLY TAVR trial (Edwards) looks at transcatheter aortic valve replacement (TAVR) as an effective treatment for patients with asymptomatic aortic stenosis. Patients are randomized to either treatment with TAVR or clinical surveillance until the develop symptoms, at which point they are eligible to be treated with TAVR.
https://clinicaltrials.gov/ct2/show/NCT03042104
Early TAVR: Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis
Sponsor: Edwards Lifesciences
To establish the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Non-randomized against medical management then TAVR when symptomatic
Randomized: TAVR vs medical management then TAVR when symptomatic
Primary endpoint: Safety and Effectiveness: Freedom from a non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization through 2 years The primary endpoint will be a superiority comparison using the log-rank test to compare the survival curves through 2 years.
Secondary endpoint: Death or disabling stroke.
Criteria
Inclusion Criteria:
More information: https://clinicaltrials.gov/ct2/show/NCT03042104
Sponsor: Edwards Lifesciences
To establish the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Non-randomized against medical management then TAVR when symptomatic
Randomized: TAVR vs medical management then TAVR when symptomatic
Primary endpoint: Safety and Effectiveness: Freedom from a non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization through 2 years The primary endpoint will be a superiority comparison using the log-rank test to compare the survival curves through 2 years.
Secondary endpoint: Death or disabling stroke.
Criteria
Inclusion Criteria:
- Severe aortic stenosis
- Patient is asymptomatic defined as:
- Negative treadmill stress test OR Per physician after thorough assessment of patient history if the patient is unable to perform a stress test.
- LV ejection fraction ≥50%
- 65 years of age or older at time of randomization
- Patient is symptomatic.
- Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
- Aortic valve is a unicuspid, bicuspid with unfavorable features for TAVR or is non-calcified.
- Severe aortic regurgitation (>3+).
- Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
More information: https://clinicaltrials.gov/ct2/show/NCT03042104
