The Nordic Aortic Valve Intervention Trial

NCT01057173 | Active Not Recruiting

• 1 other identifier: HA2009046
• Study Type: interventional
• Target: 280
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Critical Aortic Stenosis

Keywords

Heart Valve Disease; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Combined rate of death from any cause, myocardial infarction, and stroke

  Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)

  1 year

Secondary Outcomes (5)

• Procedural complications

  Within first 30 days

• Admission lengths (ICU and interventional center)

  Within first 30 days

• Combined rate of noncardiac and cardiac death, prosthesis reintervention, cardiac-, cerebral-, renal-, and pulmonary complications

  1 year

• Functional status (NYHA-classification) and Quality of Life (SF-36)

  1 year

• Echocardiographic prosthesis and ventricular structural and functional status

  1 year

Study Arms (2)

Transcatheter Aortic Valve Implantation

EXPERIMENTAL

Procedure: Transcatheter Aortic Valve Implantation

Surgical Aortic Valve Replacement

ACTIVE COMPARATOR

Procedure: Surgical Aortic Valve Replacement

Interventions

Transcatheter Aortic Valve Implantation PROCEDURE

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)

Also known as: TAVI

Transcatheter Aortic Valve Implantation

Surgical Aortic Valve Replacement PROCEDURE

Conventional surgical aortic valve replacement with a bio-prosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest

Also known as: SAVR

Surgical Aortic Valve Replacement

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Odense University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Danish Heart Foundation: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (3)

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (11)

• Thyregod HG, Sondergaard L, Ihlemann N, Franzen O, Andersen LW, Hansen PB, Olsen PS, Nissen H, Winkel P, Gluud C, Steinbruchel DA. The Nordic aortic valve intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial. Trials. 2013 Jan 9;14:11. doi: 10.1186/1745-6215-14-11.

  PMID: 23302232 BACKGROUND

• Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Sondergaard L. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015 May 26;65(20):2184-94. doi: 10.1016/j.jacc.2015.03.014. Epub 2015 Mar 15.

  PMID: 25787196 RESULT

• Thyregod HG, Steinbruchel DA, Ihlemann N, Ngo TA, Nissen H, Kjeldsen BJ, Chang Y, Hansen PB, Olsen PS, Sondergaard L. No clinical effect of prosthesis-patient mismatch after transcatheter versus surgical aortic valve replacement in intermediate- and low-risk patients with severe aortic valve stenosis at mid-term follow-up: an analysis from the NOTION trial. Eur J Cardiothorac Surg. 2016 Oct;50(4):721-728. doi: 10.1093/ejcts/ezw095. Epub 2016 Mar 22.

  PMID: 27005980 RESULT

• Sondergaard L, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Ngo AT, Olsen NT, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Olsen PS, Thyregod HG. Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial. Circ Cardiovasc Interv. 2016 Jun;9(6):e003665. doi: 10.1161/CIRCINTERVENTIONS.115.003665.

  PMID: 27296202 RESULT

• Ngo A, Hassager C, Thyregod HGH, Sondergaard L, Olsen PS, Steinbruchel D, Hansen PB, Kjaergaard J, Winther-Jensen M, Ihlemann N. Differences in left ventricular remodelling in patients with aortic stenosis treated with transcatheter aortic valve replacement with corevalve prostheses compared to surgery with porcine or bovine biological prostheses. Eur Heart J Cardiovasc Imaging. 2018 Jan 1;19(1):39-46. doi: 10.1093/ehjci/jew321.

  PMID: 28158582 RESULT

• Gronlykke L, Ihlemann N, Ngo AT, Thyregod HG, Kjaergaard J, Korshin A, Gustafsson F, Hassager C, Nilsson JC, Sondergaard L, Ravn HB. Measures of right ventricular function after transcatheter versus surgical aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Feb 1;24(2):181-187. doi: 10.1093/icvts/ivw350.

  PMID: 27811168 RESULT

• Jorgensen TH, Thyregod HG, Tarp JB, Svendsen JH, Sondergaard L. Temporal changes of new-onset atrial fibrillation in patients randomized to surgical or transcatheter aortic valve replacement. Int J Cardiol. 2017 May 1;234:16-21. doi: 10.1016/j.ijcard.2017.02.098. Epub 2017 Feb 24.

  PMID: 28258844 RESULT

• Thyregod HGH, Ihlemann N, Jorgensen TH, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Steinbruuchel DA, Olsen PS, Sondergaard L. Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk. Circulation. 2019 Jun 11;139(24):2714-2723. doi: 10.1161/CIRCULATIONAHA.118.036606. Epub 2019 Feb 1.

  PMID: 30704298 RESULT

• Sondergaard L, Ihlemann N, Capodanno D, Jorgensen TH, Nissen H, Kjeldsen BJ, Chang Y, Steinbruchel DA, Olsen PS, Petronio AS, Thyregod HGH. Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk. J Am Coll Cardiol. 2019 Feb 12;73(5):546-553. doi: 10.1016/j.jacc.2018.10.083.

  PMID: 30732707 RESULT

• Geisler BP, Jorgensen TH, Thyregod HGH, Pietzsch JB, Sondergaard L. Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients at lower surgical risk: results from the NOTION trial. EuroIntervention. 2019 Dec 6;15(11):e959-e967. doi: 10.4244/EIJ-D-18-00847.

  PMID: 31422922 RESULT

• Jorgensen TH, Thyregod HGH, Ihlemann N, Nissen H, Petursson P, Kjeldsen BJ, Steinbruchel DA, Olsen PS, Sondergaard L. Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur Heart J. 2021 Aug 7;42(30):2912-2919. doi: 10.1093/eurheartj/ehab375.

  PMID: 34179981 RESULT

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: December 1, 2009
• Primary Completion: April 1, 2014
• Study Completion (Estimated): April 1, 2033
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

SE (1); DK (2)