Active, not recruiting
Not applicable
The Nordic Aortic Valve Intervention Trial
Condition(s) studied
Critical Aortic Stenosis
Investigational drug(s) / intervention(s)
Transcatheter Aortic Valve ImplantationSurgical Aortic Valve Replacement
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)
Surgical Aortic Valve Replacement: Conventional surgical aortic valve replacement with a bio-prosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest
Study summary
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.
Eligibility
Inclusion Criteria:
* Patients must have severe degenerative aortic valve stenosis (echocardiographic criteria: AV effective orifice area (EOA) of \< 1 cm2, mean AV gradient of \> 40 mmHg, or AV peak systolic velocity of \> 4.0 m/s)
* Patients must be symptomatic from the aortic valve stenosis (dyspnoea in NYHA-class II or greater, angina pectoris, or syncope), or asymptomatic but with echocardiographic evidence of left ventricular hypertrophy, decreased left ventricular ejection fraction, or atrial fibrillation)
* Patients must be 70 years or older
* Patients must be technical and anatomical eligible for both interventions (as specified by Medtronic CoreValve(TM) for the TAVI procedure) after a formal consult by a cardiologist and a cardiovascular surgeon
* Patients must be expected to survive more than one year after the intervention
* Patients must be able to provide written informed consent as approved by the regional ethical committee after having received adequate information about the study
* Patients must be able and agree to return to all post-procedural follow-up visits
Exclusion Criteria:
* Isolated aortic valve insufficiency
* Other significant heart valve disease requiring intervention
* Coronary artery co-morbidity requiring revascularisation
* Any previous open heart surgery
* Myocardial infarction or percutaneous coronary intervention within the last year
* Stroke or TIA within the last 30 days
* Renal insufficiency requiring hemodialysis
* Pulmonary insufficiency (FEV1 or diffusion capacity \< 40% of expected)
* Active infectious disease requiring antibiotics
* Emergency intervention (within 24 hours after the indication for intervention has been made)
* Unstable pre-interventional condition requiring inotropic support or mechanical heart assistance
* A known hypersensitivity or contraindication to heparin or nitinol
* Currently participating in an investigational drug or another device study
Primary outcome measure(s)
- Combined rate of death from any cause, myocardial infarction, and stroke — 1 year
Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)
Trial sites (3)
| Facility | City | Region | Status |
| Copenhagen University Hospital |
Copenhagen |
Denmark |
|
| Odense University Hospital |
Odense |
Denmark |
|
| Sahlgrenska University Hospital |
Gothenburg |
Sweden |
|
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