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Clinical Trials in Sweden / NCT02825134
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Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

NCT02825134 · tracked via the Priya Life Science Sweden tracker
Sponsor
Ole De Backer
Phase
Not applicable
Started
2016-06-30
Last updated
2024-04-09

Condition(s) studied

Aortic Valve StenosisCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesVentricular Outflow Obstruction

Investigational drug(s) / intervention(s)

Transcatheter aortic valve replacementSurgical aortic valve replacement

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02825134 on ClinicalTrials.gov ↗ ← All trials in Sweden