Aortic Valve StenosisNOTION-2NCT02825134
Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis
A study testing Transcatheter aortic valve replacement and Surgical aortic valve replacement in people with Aortic Valve Stenosis and Cardiovascular Diseases, run by Ole De Backer at 9 sites in 5 countries.
Trial summary
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Transcatheter aortic valve replacement and Surgical aortic valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 30 Jun 2016to Jun 2029
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 75 years or younger.
- Severe calcific AS (Valve area <1cm2 (or <0.6 cm2/m2) AND one of the two following criteria: mean gradient >40mmHg or peak jet velocity >4.0m/s, OR in presence of low flow, low gradient with reduced or normal LVEF<50%, a dobutamine stress echo should verify true severe AS rather than pseudo-AS
- Symptomatic with angina pectoris, dyspnea or exercise-induced syncope or near syncope OR asymptomatic with abnormal exercise test showing symptoms on exercise clearly related to AS or systolic LV dysfunction (LVEF <50%) not due to another cause.
- Anticipated usage of biological aortic valve prosthesis.
- Low risk for conventional surgery (STS Score <4%).
- Suitable for both SAVR and transfemoral TAVR.
- Life expectancy >1 year after the intervention.
- Informed consent to participate in the study after adequate information about the study before randomization and intervention.
Who cannot join
- Coronary artery disease, not suitable for both percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).
- Coronary angiogram with a SYNTAX-score >22.
- LVEF <25% without contractile reserve during dobutamine stress echocardiography.
- Porcelain aorta, which prevents open-heart surgery.
- Bicuspid valve with aorta ascendens diameter ≥45mm
- Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.
Show all 14Show fewer
- Need for open heart surgery other than SAVR with or without CABG.
- Myocardial infarction within last 30 days
- Stroke or TIA within the last 30 days. NOTION-2, 01. February 2017, version 5 9
- Current endocarditis, intracardiac tumor, thrombus or vegetation.
- Ongoing severe infection requiring intravenous antibiotics.
- Unstable pre-procedural condition requiring intravenous inotropes or mechanical assist device (IABP, Impella) on the day of intervention.
- Kidney disease requiring dialysis or severely impaired lung function (FEV1 and/or diffusion capacity <40% of predicted).
- Allergy to heparin, iodid contrast agent, warfarin, aspirin or clopidogrel.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Finland3 sites
Helsinki University Central Hospital
Helsinki, FI00029
Oulu University Hospital
Oulu, 90220
Turku University Hospital
Turku, 20520
Denmark2 sites
Aarhus University hospital
Aarhus, 8000
Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: Nordic Aortic Valve Intervention Trial 2 - A Randomized Multicenter Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in Younger Low Surgical Risk Patients With Severe Aortic Stenosis
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.
Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.
Read the detailed description
BACKGROUND: Acquired aortic valve stenosis (AS) is the most common heart valve disease in the Western World with a prevalence of 2-7% at the age of >65 years. If untreated, it may lead to heart failure and death. Surgical aortic valve replacement (SAVR) until recent years has been the definitive treatment for patients with severe symptomatic AS. A less invasive transcatheter aortic valve replacement (TAVR) has been developed and has been a treatment of choice mostly for elderly high risk or inoperable patients. As TAVR technology is continuously evolving and improving, it may be anticipated that it will become a valuable alternative - and even the preferred choice of treatment - for younger, low-risk patients with severe aortic valve stenosis in the near future. However, to date, there is no clinical evidence that supports this hypothesis.
AIM: The purpose of the study is to compare TAVR and SAVR with regard to the intra- and post-procedural morbidity and mortality rate, hospitalization length, functional capacity, quality of life, and valvular prosthesis function in younger, low risk patients with severe bicuspid or tricuspid AS, scheduled for aortic valve replacement.
POPULATION: Younger low risk patients with severe aortic valve stenosis, which are scheduled for aortic valve replacement using a bioprosthesis. Subjects fulfilling the inclusion criteria, not having any exclusion criteria, and consenting to the trial will be randomized 1:1 to TAVR or SAVR with 186 patients in each group.
DESIGN: The study is a randomized clinical multicenter trial. Central randomization with variable block size and stratification by gender and coronary comorbidity will be used. An independent event committee blinded to treatment allocation will adjudicate safety endpoints.
INTERVENTIONS:
TAVR: Any CE-Mark approved transcatheter aortic bioprosthesis may be used in the study, and the choice is at the discretion of the local TAVR team. The transfemoral TAVR procedure may be performed under general anaesthesia, local anaesthesia/conscious sedation, or local anesthesia. Percutaneous coronary intervention (PCI) can be performed up to 30 days prior to TAVR or as a hybrid procedure.
SAVR: The surgical SAVR technique follows standard protocol of the local department of cardio-thoracic surgery. The operation is performed under general anesthesia, which follows standard protocol of the department of anesthesiology. A commercial available surgical aortic bioprosthesis at the surgeons discretion will be implanted. Concomitant coronary artery bypass graft (CABG) surgery may be performed.
END POINTS: The primary endpoint is the composite rate of death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure) within one year after the procedure. Secondary endpoints are listed below. Follow-up will be performed after 1 and 12 months and yearly thereafter for a minimum of 10 years.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
- Being tested
- Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Keywords
- heart valve disease, valvular bioprosthesis, aortic valve replacement, Randomized clinical trial
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementDevice
Also called Transcatheter aortic valve implantation, TAVR, TAVI
Retrograde transfemoral transcatheter aortic valve replacement with any CE mark approved aortic bioprosthesis with or without concomitant percutaneous coronary intervention.
Surgical aortic valve replacementDevice
Also called SAVR
Conventional surgical aortic valve replacement with a bioprosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest with or without concomitant coronary artery bypass graft surgery.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter aortic valve replacement | Experimental | Transcatheter aortic valve replacement Receives: Device: Transcatheter aortic valve replacement |
| Surgical aortic valve replacement | Active comparator | Surgical aortic valve replacement Receives: Device: Surgical aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of all-cause mortality, stroke and rehospitalization (related to the procedure, the valve or heart failure) within one year after the procedure.
VARC-3 definitions
Measured: at one year post-procedural.
Secondary outcomes (26)
Procedure time
hours
Measured: Intraoperative
Duration of index hospitalization
days
Measured: Number of days from admission to discharge (expected an averge of 7 days)
Composite rate of all-cause mortality, stroke and rehospitalization (related to the procedure, the valve or heart failure)
VARC-3 definitions
Measured: at 1 month and yearly thereafter up to 10 years post-procedure
Composite rate of all-cause mortality, disabling stroke and rehospitalization (related to the procedure, the valve or heart failure)
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Rehospitalization both composite and individual of related to the procedure, the valve or heart failure)
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Composite rate of all-cause mortality and disabling stroke
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
All-cause mortality
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Cardiovascular mortality
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Non-cardiovascular mortality
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Stroke
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Disabling Stroke
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Non-disabling stroke
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Transient Ischemic attack
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Myocardial Infarction
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Endocarditis
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Valve Thrombosis
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Need for aortic valve re-intervention
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Bleeding (life-threatening or major)
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Vascular complication (major)
VARC-3 defintions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Acute kidney injury (stage 2 or 3)
VARC-3 defintions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Echocardiographic aortic bioprosthesis performance (degree of paravalvular leakage, valve area, mean gradient, prosthesis patient mismatch)
VARC-3 definitions
Measured: at discharge, 1 and 12 months, and yearly thereafter up to 10 years post-procedure
NYHA functional class
NYHA functional class
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Need for permanent pacemaker
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
New onset atrial fibrillation captured on ECG
VARC-3 definitions
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Left ventricle remodeling as assesed by echocardiography
Left ventricle internal diameter in diastoli
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Quality of life change from baseline
Kansas City Cardiomyopathy Questionnaire, scale 0 (worse) to 100 (better)
Measured: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start30 Jun 2016
- Primary completionFeb 2024
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- 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
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ole De Backer
- Sponsor type
- University, hospital or other
- Collaborators
- Symetis SA, Boston Scientific Corporation, Abbott, Edwards Lifesciences
- Responsible party
- Sponsor-investigator, Ole De Backer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ole De Backer, MD; PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletHans GH Thyregod, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825134
- Sponsor's protocol ID
- H-15019580
- Acronym
- NOTION-2
- Status last verified
- Apr 2024
- First submitted
- 29 Jun 2016
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jorgensen TH, Savontaus M, Willemen Y, Bleie O, Tang M, Angeras O, Niemela M, Gudmundsdottir IJ, Khokhar A, Sartipy U, Dagnegard H, Laine M, Ruck A, Piuhola J, Petursson P, Christiansen EH, Malmberg M, Olsen PS, Haaverstad R, Prendergast B, Sondergaard L, Horsted Thyregod HG, De Backer O; NOTION-2 Investigators. Three-Year Follow-Up of the NOTION-2 Trial: TAVR Versus SAVR to Treat Younger Low-Risk Patients With Tricuspid or Bicuspid Aortic Stenosis. Circulation. 2025 Nov 11;152(19):1326-1337. doi: 10.1161/CIRCULATIONAHA.125.076678. Epub 2025 Aug 30.
PubMed 40884768Jorgensen TH, Thyregod HGH, Blankenberg S, Leon M, Sondergaard L, Prendergast B, De Backer O. The low-risk TAVR trials-A critical appraisal of the current landscape. Am Heart J. 2026 Jan;291:10-13. doi: 10.1016/j.ahj.2025.07.070. Epub 2025 Jul 29.
PubMed 40744194Jorgensen TH, Thyregod HGH, Savontaus M, Willemen Y, Bleie O, Tang M, Niemela M, Angeras O, Gudmundsdottir IJ, Sartipy U, Dagnegaard H, Laine M, Ruck A, Piuhola J, Petursson P, Christiansen EH, Malmberg M, Olsen PS, Haaverstad R, Sondergaard L, De Backer O; NOTION-2 investigators. Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial. Eur Heart J. 2024 Oct 5;45(37):3804-3814. doi: 10.1093/eurheartj/ehae331.
PubMed 38747246
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Aortic Valve Intervention Trial 2 - A Randomized Multicenter Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in Younger Low Surgical Risk Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT02825134
- Acronym / sponsor ID
- NOTION-2 / H-15019580
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
- Keywords
- heart valve disease, valvular bioprosthesis, aortic valve replacement, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Ole De BackerUniversity, hospital or other
- Collaborators
- Symetis SA, Boston Scientific Corporation, Abbott, Edwards Lifesciences
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- Feb 2024 (actual)
- Study completion
- Jun 2029 (estimated)
- First posted
- 7 Jul 2016 (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 investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.
Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.
Detailed description
BACKGROUND: Acquired aortic valve stenosis (AS) is the most common heart valve disease in the Western World with a prevalence of 2-7% at the age of >65 years. If untreated, it may lead to heart failure and death. Surgical aortic valve replacement (SAVR) until recent years has been the definitive treatment for patients with severe symptomatic AS. A less invasive transcatheter aortic valve replacement (TAVR) has been developed and has been a treatment of choice mostly for elderly high risk or inoperable patients. As TAVR technology is continuously evolving and improving, it may be anticipated that it will become a valuable alternative - and even the preferred choice of treatment - for younger, low-risk patients with severe aortic valve stenosis in the near future. However, to date, there is no clinical evidence that supports this hypothesis.
AIM: The purpose of the study is to compare TAVR and SAVR with regard to the intra- and post-procedural morbidity and mortality rate, hospitalization length, functional capacity, quality of life, and valvular prosthesis function in younger, low risk patients with severe bicuspid or tricuspid AS, scheduled for aortic valve replacement.
POPULATION: Younger low risk patients with severe aortic valve stenosis, which are scheduled for aortic valve replacement using a bioprosthesis. Subjects fulfilling the inclusion criteria, not having any exclusion criteria, and consenting to the trial will be randomized 1:1 to TAVR or SAVR with 186 patients in each group.
DESIGN: The study is a randomized clinical multicenter trial. Central randomization with variable block size and stratification by gender and coronary comorbidity will be used. An independent event committee blinded to treatment allocation will adjudicate safety endpoints.
INTERVENTIONS:
TAVR: Any CE-Mark approved transcatheter aortic bioprosthesis may be used in the study, and the choice is at the discretion of the local TAVR team. The transfemoral TAVR procedure may be performed under general anaesthesia, local anaesthesia/conscious sedation, or local anesthesia. Percutaneous coronary intervention (PCI) can be performed up to 30 days prior to TAVR or as a hybrid procedure.
SAVR: The surgical SAVR technique follows standard protocol of the local department of cardio-thoracic surgery. The operation is performed under general anesthesia, which follows standard protocol of the department of anesthesiology. A commercial available surgical aortic bioprosthesis at the surgeons discretion will be implanted. Concomitant coronary artery bypass graft (CABG) surgery may be performed.
END POINTS: The primary endpoint is the composite rate of death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure) within one year after the procedure. Secondary endpoints are listed below. Follow-up will be performed after 1 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 replacement | Experimental | Device: Transcatheter aortic valve replacementTranscatheter aortic valve replacement |
| Surgical aortic valve replacement | Active comparator | Device: Surgical aortic valve replacementSurgical aortic valve replacement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 75 years or younger.
- Severe calcific AS (Valve area <1cm2 (or <0.6 cm2/m2) AND one of the two following criteria: mean gradient >40mmHg or peak jet velocity >4.0m/s, OR in presence of low flow, low gradient with reduced or normal LVEF<50%, a dobutamine stress echo should verify true severe AS rather than pseudo-AS
- Symptomatic with angina pectoris, dyspnea or exercise-induced syncope or near syncope OR asymptomatic with abnormal exercise test showing symptoms on exercise clearly related to AS or systolic LV dysfunction (LVEF <50%) not due to another cause.
- Anticipated usage of biological aortic valve prosthesis.
- Low risk for conventional surgery (STS Score <4%).
Key exclusion criteria (14 listed)
- Coronary artery disease, not suitable for both percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).
- Coronary angiogram with a SYNTAX-score >22.
- LVEF <25% without contractile reserve during dobutamine stress echocardiography.
- Porcelain aorta, which prevents open-heart surgery.
- Bicuspid valve with aorta ascendens diameter ≥45mm
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 replacementAlso: Transcatheter aortic valve implantation, TAVR, TAVIRetrograde transfemoral transcatheter aortic valve replacement with any CE mark approved aortic bioprosthesis with or without concomitant percutaneous coronary intervention. | Device | Transcatheter aortic valve replacement |
| Surgical aortic valve replacementAlso: SAVRConventional surgical aortic valve replacement with a bioprosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest with or without concomitant coronary artery bypass graft surgery. | Device | Surgical aortic valve replacement |
Primary outcome
Composite rate of all-cause mortality, stroke and rehospitalization (related to the procedure, the valve or heart failure) within one year after the procedure.
Time frame: at one year post-procedural.
VARC-3 definitions
26 secondary outcomes
Procedure time
Time frame: Intraoperative
Duration of index hospitalization
Time frame: Number of days from admission to discharge (expected an averge of 7 days)
Composite rate of all-cause mortality, stroke and rehospitalization (related to the procedure, the valve or heart failure)
Time frame: at 1 month and yearly thereafter up to 10 years post-procedure
Composite rate of all-cause mortality, disabling stroke and rehospitalization (related to the procedure, the valve or heart failure)
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Rehospitalization both composite and individual of related to the procedure, the valve or heart failure)
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Composite rate of all-cause mortality and disabling stroke
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
All-cause mortality
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Cardiovascular mortality
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Non-cardiovascular mortality
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Stroke
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Disabling Stroke
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Non-disabling stroke
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Transient Ischemic attack
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Myocardial Infarction
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Endocarditis
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Valve Thrombosis
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Need for aortic valve re-intervention
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Bleeding (life-threatening or major)
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Vascular complication (major)
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Acute kidney injury (stage 2 or 3)
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Echocardiographic aortic bioprosthesis performance (degree of paravalvular leakage, valve area, mean gradient, prosthesis patient mismatch)
Time frame: at discharge, 1 and 12 months, and yearly thereafter up to 10 years post-procedure
NYHA functional class
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Need for permanent pacemaker
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
New onset atrial fibrillation captured on ECG
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Left ventricle remodeling as assesed by echocardiography
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
Quality of life change from baseline
Time frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure
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 9 Apr 2024.
- Derived from this study: PubMed 40884768Jorgensen TH, Savontaus M, Willemen Y, Bleie O, Tang M, Angeras O, Niemela M, Gudmundsdottir IJ, Khokhar A, Sartipy U, Dagnegard H, Laine M, Ruck A, Piuhola J, Petursson P, Christiansen EH, Malmberg M, Olsen PS, Haaverstad R, Prendergast B, Sondergaard L, Horsted Thyregod HG, De Backer O; NOTION-2 Investigators. Three-Year Follow-Up of the NOTION-2 Trial: TAVR Versus SAVR to Treat Younger Low-Risk Patients With Tricuspid or Bicuspid Aortic Stenosis. Circulation. 2025 Nov 11;152(19):1326-1337. doi: 10.1161/CIRCULATIONAHA.125.076678. Epub 2025 Aug 30.
- Derived from this study: PubMed 40744194Jorgensen TH, Thyregod HGH, Blankenberg S, Leon M, Sondergaard L, Prendergast B, De Backer O. The low-risk TAVR trials-A critical appraisal of the current landscape. Am Heart J. 2026 Jan;291:10-13. doi: 10.1016/j.ahj.2025.07.070. Epub 2025 Jul 29.
- Derived from this study: PubMed 38747246Jorgensen TH, Thyregod HGH, Savontaus M, Willemen Y, Bleie O, Tang M, Niemela M, Angeras O, Gudmundsdottir IJ, Sartipy U, Dagnegaard H, Laine M, Ruck A, Piuhola J, Petursson P, Christiansen EH, Malmberg M, Olsen PS, Haaverstad R, Sondergaard L, De Backer O; NOTION-2 investigators. Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial. Eur Heart J. 2024 Oct 5;45(37):3804-3814. doi: 10.1093/eurheartj/ehae331.
- Individual participant dataSharing planned: No
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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.
Ole De Backer, MD; PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
Hans GH Thyregod, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve replacement and Surgical aortic valve replacement in people with Aortic Valve Stenosis and Cardiovascular Diseases, run by Ole De Backer at 9 sites in 5 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 8 inclusion and 14 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Finland, Denmark, Sweden, Iceland, Norway. 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?
Composite rate of all-cause mortality, stroke and rehospitalization (related to the procedure, the valve or heart failure) within one year after the procedure. (time frame: at one year post-procedural.). 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 NCT02825134, which also lists 3 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 9 Apr 2024.