Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT02825134
• Date of registration: 29/06/2016
• Prospective Registration: Yes
• Primary sponsor: Ole De Backer
• Public title: Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis NOTION-2
• Scientific 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
• Date of first enrolment: June 30, 2016
• Target sample size: 376
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02825134
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark, Finland, Iceland, Norway, Sweden

Contacts

• Name: Ole De Backer, MD; PhD
• Affiliation: Rigshospitalet, Denmark

• Name: Hans GH Thyregod, MD, PhD
• Affiliation: Rigshospitalet, Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ventricular Outflow Obstruction

Aortic Valve Stenosis

Heart Diseases

Cardiovascular Diseases

Heart Valve Diseases

Intervention(s)

Device: Surgical aortic valve replacement

Device: Transcatheter aortic valve replacement

Primary Outcome(s)

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.]

Secondary Outcome(s)

All-cause mortality [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]

Quality of life change from baseline [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]

Duration of index hospitalization [Time Frame: Number of days from admission to discharge (expected an averge of 7 days)]

Left ventricle remodeling as assesed by echocardiography [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]

Myocardial Infarction [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]

Valve Thrombosis [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]

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]

Endocarditis [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]

Procedure time [Time Frame: Intraoperative]

Transient Ischemic attack [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]

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]

Bleeding (life-threatening or major) [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]

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]

NYHA functional class [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]

Stroke [Time Frame: at 1 and 12 months, and yearly thereafter up to 10 years post-procedure]

Secondary ID(s)

H-15019580

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Symetis SA

Abbott

Edwards Lifesciences

Boston Scientific Corporation