Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Not applicable

The Nordic Aortic Valve Intervention Trial

NCT01057173 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2009-12
Last updated
2023-11-22

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

Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Copenhagen University Hospital Copenhagen Denmark
Odense University Hospital Odense Denmark
Sahlgrenska University Hospital Gothenburg Sweden
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 NCT01057173 on ClinicalTrials.gov ↗ ← All trials in Denmark