title: The Nordic aortic valve intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting.
  
  
  METHODS
  This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012.
  
  
  CONCLUSIONS
  The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01057173.
authors.affiliation: Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark. hgthyregod@gmail.com
authors.forename: Hans Gustav
authors.initials: HG
authors.lastname: Thyregod
authors.forename: Lars
authors.initials: L
authors.lastname: Søndergaard
authors.forename: Nikolaj
authors.initials: N
authors.lastname: Ihlemann
authors.forename: Olaf
authors.initials: O
authors.lastname: Franzen
authors.forename: Lars Willy
authors.initials: LW
authors.lastname: Andersen
authors.forename: Peter Bo
authors.initials: PB
authors.lastname: Hansen
authors.forename: Peter Skov
authors.initials: PS
authors.lastname: Olsen
authors.forename: Henrik
authors.initials: H
authors.lastname: Nissen
authors.forename: Per
authors.initials: P
authors.lastname: Winkel
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Daniel Andreas
authors.initials: DA
authors.lastname: Steinbrüchel
mesh_terms: D000368:Aged; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D002985:Clinical Protocols; D003718:Denmark; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology; D011474:Prosthesis Design; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome