Critical Aortic StenosisNOTIONNCT01057173
The Nordic Aortic Valve Intervention Trial
A study testing Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in people with Critical Aortic Stenosis, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Critical Aortic Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2009to Apr 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Copenhagen University Hospital
Copenhagen, 2100
Odense University Hospital
Odense, 5000
About this study
Official title: Transcatheter Versus Surgical Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis
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.
Read the detailed description
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.
- Conditions
- Critical Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Keywords
- Heart Valve Disease, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Randomized Controlled Trial
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationProcedure or surgery
Also called TAVI
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 ReplacementProcedure or surgery
Also called SAVR
Conventional surgical aortic valve replacement with a bio-prosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Implantation | Experimental | Not described Receives: Procedure: Transcatheter Aortic Valve Implantation |
| Surgical Aortic Valve Replacement | Active comparator | Not described Receives: Procedure: Surgical Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (5)
Procedural complications
Measured: Within first 30 days
Admission lengths (ICU and interventional center)
Measured: Within first 30 days
Combined rate of noncardiac and cardiac death, prosthesis reintervention, cardiac-, cerebral-, renal-, and pulmonary complications
Measured: 1 year
Functional status (NYHA-classification) and Quality of Life (SF-36)
Measured: 1 year
Echocardiographic prosthesis and ventricular structural and functional status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2014
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Critical Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sahlgrenska University Hospital, Danish Heart Foundation, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Principal investigator, Hans Gustav Hørsted Thyregod, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hans GH Thyregod, MD, PhD, Principal investigator, Dep. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University HospitalLars Søndergaard, MD, DMSc, Principal investigator, Dep. of Cardiology, Rigshospitalet, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057173
- Sponsor's protocol ID
- HA2009046
- Acronym
- NOTION
- Status last verified
- Nov 2023
- First submitted
- 26 Jan 2010
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23302232Thyregod 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.
PubMed 25787196Thyregod 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.
PubMed 27005980Sondergaard 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.
PubMed 27296202Ngo 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.
PubMed 28158582Gronlykke 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.
PubMed 27811168Jorgensen 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.
PubMed 28258844Thyregod 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.
PubMed 30704298Sondergaard 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.
PubMed 30732707Geisler 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.
PubMed 31422922Jorgensen 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.
PubMed 34179981
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Versus Surgical Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT01057173
- Acronym / sponsor ID
- NOTION / HA2009046
- Conditions
- Critical Aortic Stenosis
- Keywords
- Heart Valve Disease, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sahlgrenska University Hospital, Danish Heart Foundation, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- Dec 2009 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2033 (estimated)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Implantation | Experimental | Procedure: Transcatheter Aortic Valve Implantation |
| Surgical Aortic Valve Replacement | Active comparator | Procedure: Surgical Aortic Valve Replacement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ImplantationAlso: TAVIRetrograde trans-femoral or trans-subclavian aortic valve implantation with the Medtronic CoreValve System(TM) bio-prosthesis (third generation system, 18 Fr, CE mark approved) | Procedure or surgery | Transcatheter Aortic Valve Implantation |
| Surgical Aortic Valve ReplacementAlso: SAVRConventional surgical aortic valve replacement with a bio-prosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest | Procedure or surgery | Surgical Aortic Valve Replacement |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 23302232Thyregod 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.
- Results publication: PubMed 25787196Thyregod 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.
- Results publication: PubMed 27005980Thyregod 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.
- Results publication: PubMed 27296202Sondergaard 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.
- Results publication: PubMed 28158582Ngo 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.
- Results publication: PubMed 27811168Gronlykke 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.
- Results publication: PubMed 28258844Jorgensen 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.
- Results publication: PubMed 30704298Thyregod 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.
- Results publication: PubMed 30732707Sondergaard 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.
- Results publication: PubMed 31422922Geisler 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.
- Results publication: PubMed 34179981Jorgensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans GH Thyregod, MD, PhD principal investigator
Dep. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
Lars Søndergaard, MD, DMSc principal investigator
Dep. of Cardiology, Rigshospitalet, Copenhagen University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in people with Critical Aortic Stenosis, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined rate of death from any cause, myocardial infarction, and stroke (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057173, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.