The Nordic Aortic Valve Intervention Trial (NOTION)
A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age suffering from severe aortic valve stenosis.
Study hypothesis: TAVI will reduce post-interventional morbidity and mortality compared to SAVR.
|Critical Aortic Stenosis||Procedure: Transcatheter Aortic Valve Implantation Procedure: Surgical Aortic Valve Replacement|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Transcatheter Versus Surgical Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis|
- Combined rate of death from any cause, myocardial infarction, and stroke [ Time Frame: 1 year ]Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)
- Procedural complications [ Time Frame: Within first 30 days ]
- Admission lengths (ICU and interventional center) [ Time Frame: Within first 30 days ]
- Combined rate of noncardiac and cardiac death, prosthesis reintervention, cardiac-, cerebral-, renal-, and pulmonary complications [ Time Frame: 1 year ]
- Functional status (NYHA-classification) and Quality of Life (SF-36) [ Time Frame: 1 year ]
- Echocardiographic prosthesis and ventricular structural and functional status [ Time Frame: 1 year ]
|Actual Study Start Date:||December 2009|
|Estimated Study Completion Date:||April 2023|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Experimental: Transcatheter Aortic Valve Implantation||
Procedure: Transcatheter Aortic Valve Implantation
Retrograde trans-femoral or trans-subclavian aortic valve implantation with the Medtronic CoreValve System(TM) bio-prosthesis (third generation system, 18 Fr, CE mark approved)
Other Name: TAVI
|Active Comparator: Surgical Aortic Valve Replacement||
Procedure: Surgical Aortic Valve Replacement
Conventional surgical aortic valve replacement with a bio-prosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest
Other Name: SAVR
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a new and rapidly evolving treatment option for patients with severe degenerative aortic valve stenosis. Short- and mid-term results with transcatheter valve prostheses are promising in high-risk surgical patients, but long-term results are lacking. TAVI could potentially be an attractive minimally invasive treatment also for patients with moderate and low surgical risk, but no comparison has been made with the standard surgical treatment for aortic valve stenosis.
AIM: To compare TAVI and surgical aortic valve replacement (SAVR) in patients with severe aortic valve stenosis.
POPULATION: All patients with severe degenerative aortic valve stenosis referred for elective or subacute aortic valve intervention will be screened for study eligibility. To be included subjects must be 70 years or older, anatomical and technical eligible for both interventions, expected to survive more than 1 year after the intervention, and able to provide written informed consent. Study exclusion criteria include isolated aortic valve regurgitation or other significant valve disease, coronary artery disease requiring revascularisation at the time of referral, previous open heart surgery, a myocardial infarction or percutaneous coronary intervention within the last year, a cerebral infarction within the previous 30 days, severe renal -, pulmonary -, or infectious disease, and unstable preoperative condition.
DESIGN: The project is a national multicenter randomized clinical trial. Patients fulfilling all inclusion- and no exclusion criteria will be randomized to either TAVI or SAVR. Randomization will be 1:1 with 140 subjects in each group and stratified according to centre, age (70-74 years vs 75 and older), and coronary co-morbidity not requiring revascularisation (yes vs no). Primary outcome will be assessed by a blinded adjudication committee. Patients screened but not included in the study will be followed yearly. Screening and inclusion will commence in December 2009. Inclusion is expected to last 2 to 3 years, and subjects will be followed for 10 years.
INTERVENTIONS: Subjects randomized to TAVI will undergo percutaneous retrograde trans-femoral or trans-subclavian aortic valve implantation with the Medtronic CoreValve(TM) self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus will be performed. Subjects randomized to SAVR will undergo conventional surgical aortic valve replacement with a bio-prosthesis on cardiopulmonary bypass in normothermia with cold cardioplegia cardiac arrest. All interventions will be performed under general anaesthesia, and post-interventional medical and anticoagulation treatment will be uniform.
END POINTS: The primary end point is a combined outcome measure consisting of death from any cause, myocardial infarction, and stroke one year after the intervention. Secondary end points are death from any cause, cardiac death, cardiac -, cerebral -, pulmonary -, and renal complications, prosthesis re-intervention, procedure success and - time, admission lengths, functional class, quality of life, prosthesis and left ventricular structure and function. Follow-up visits will be performed after 30 days, 3, 6 and 12 months, and yearly thereafter for a minimum of 10 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057173
|Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, 413 45|
|Principal Investigator:||Hans GH Thyregod, MD, PhD||Dep. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital|
|Principal Investigator:||Lars Søndergaard, MD, DMSc||Dep. of Cardiology, Rigshospitalet, Copenhagen University Hospital|