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ACTIVE NOT RECRUITING

NCT02825134

Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

Sponsor: Ole De Backer

View on ClinicalTrials.gov

Summary

A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis. Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.

Official title: Nordic Aortic Valve Intervention Trial 2 - A Randomized Multicenter Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

376

Start Date

2016-06-30

Completion Date

2029-06

Last Updated

2024-04-09

Healthy Volunteers

Conditions

Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Interventions

DEVICE

Transcatheter aortic valve replacement

Retrograde transfemoral transcatheter aortic valve replacement with any CE mark approved aortic bioprosthesis with or without concomitant percutaneous coronary intervention.

DEVICE

Surgical aortic valve replacement

Conventional surgical aortic valve replacement with a bioprosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest with or without concomitant coronary artery bypass graft surgery.

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.

Locations (9)

Aarhus University hospital

Aarhus, Denmark

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Helsinki University Central Hospital

Helsinki, Finland

Oulu University Hospital

Oulu, Finland

Turku University Hospital

Turku, Finland

Landspital

Reykjavik, Iceland

Haukeland University Hospital

Bergen, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Karolinska University Hospital

Stockholm, Sweden