Last updated on October 2018

Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart disease | Left ventricular outflow obstruction | Aortic Stenosis | VALVULAR HEART DISEASE | Cardiovascular Disease
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 75 years or younger.
  • Severe calcific AS (Valve area <1cm2 (or <0.6 cm2/m2) AND one of the two following criteria: mean gradient >40mmHg or peak jet velocity >4.0m/s, OR in presence of low flow, low gradient with reduced or normal LVEF<50%, a dobutamine stress echo should verify true severe AS rather than pseudo-AS
  • Symptomatic with angina pectoris, dyspnea or exercise-induced syncope or near syncope OR asymptomatic with abnormal exercise test showing symptoms on exercise clearly related to AS or systolic LV dysfunction (LVEF <50%) not due to another cause.
  • Anticipated usage of biological aortic valve prosthesis.
  • Low risk for conventional surgery (STS Score <4%).
  • Suitable for both SAVR and transfemoral TAVR.
  • Life expectancy >1 year after the intervention.
  • Informed consent to participate in the study after adequate information about the study before randomization and intervention.

Exclusion Criteria:

  • Coronary artery disease, not suitable for both percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).
  • Coronary angiogram with a SYNTAX-score >22.
  • LVEF <25% without contractile reserve during dobutamine stress echocardiography.
  • Porcelain aorta, which prevents open-heart surgery.
  • Bicuspid valve with aorta ascendens diameter 45mm
  • Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.
  • Need for open heart surgery other than SAVR with or without CABG.
  • Myocardial infarction within last 30 days
  • Stroke or TIA within the last 30 days. NOTION-2, 01. February 2017, version 5 9
  • Current endocarditis, intracardiac tumor, thrombus or vegetation.
  • Ongoing severe infection requiring intravenous antibiotics.
  • Unstable pre-procedural condition requiring intravenous inotropes or mechanical assist device (IABP, Impella) on the day of intervention.
  • Kidney disease requiring dialysis or severely impaired lung function (FEV1 and/or diffusion capacity <40% of predicted).
  • Allergy to heparin, iodid contrast agent, warfarin, aspirin or clopidogrel.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.