HumRes65761
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SNCTP000006236
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BASEC2024-01713
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NCT06559332
Randomized study on strategies for assessing coronary artery disease in patients with severe aortic stenosis undergoing catheter-based aortic valve replacement
Résumé de l'étude
Narrowed coronary arteries and a narrowed aortic valve often occur together. Guidelines recommend an invasive catheter examination to assess the coronary arteries before a valve procedure. However, the benefit-risk ratio of routine invasive coronary catheterization prior to catheter-based aortic valve replacement is unclear, as the treatment of aortic stenosis itself may improve myocardial perfusion and corresponding symptoms.
(BASEC)
Intervention étudiée
The study investigates whether omitting routine coronary catheterization before treatment of aortic stenosis and further assessment of the coronary arteries only in the presence of corresponding symptoms (intervention group) is non-inferior to routine coronary catheterization (control group) regarding adverse clinical outcomes after 1 and 3 years.
(BASEC)
Maladie en cours d'investigation
Coronary artery disease in patients with severe aortic stenosis
(BASEC)
Critères de participation
- Age ≥ 70 years - Severe aortic stenosis, defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s OR if mean gradient <40 mmHg and peak velocity <4 m/s and indexed stroke volume ≤ 35 mL/m2 and LVEF ≥50%, then if CT-derived aortic valve calcification score >2000 Agatston units in men, >1300 in women OR if mean gradient <40 mmHg and Vmax <4 m/s and SVi ≤ 35 mL/m2 and LVEF <50%, then if CT-derived aortic valve calcification >2000 Agatston units in men, >1300 in women OR if low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke volume) and AVA ≤1cm2 - Selected for treatment with catheter-based aortic valve replacement via the femoral vessels (transfemoral TAVI). - Coronary calcification score ≥ 400 Agatston units (derived from routine CT prior to TAVI) or known coronary artery disease - Signed informed consent (BASEC)
Critères d'exclusion
- Associated valvular heart disease or aortic dilation with indication for surgery or intervention - Unprotected left main coronary stenosis >50% based on coronary computed tomography angiography derived from a routine CT prior to TAVI - Left ventricular ejection fraction (LV-EF) < 30% - New regional wall motion abnormality on echocardiogram - Myocardial infarction within the last 12 months - Cardiac catheterization within the last 12 months - Previous stenting of the left main coronary artery (BASEC)
- Age ≥ 70 years - Severe aortic stenosis, defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s OR if mean gradient <40 mmHg and peak velocity <4 m/s and indexed stroke volume ≤ 35 mL/m2 and LVEF ≥50%, then if CT-derived aortic valve calcification score >2000 Agatston units in men, >1300 in women OR if mean gradient <40 mmHg and Vmax <4 m/s and SVi ≤ 35 mL/m2 and LVEF <50%, then if CT-derived aortic valve calcification >2000 Agatston units in men, >1300 in women OR if low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke volume) and AVA ≤1cm2 - Selected for treatment with catheter-based aortic valve replacement via the femoral vessels (transfemoral TAVI). - Coronary calcification score ≥ 400 Agatston units (derived from routine CT prior to TAVI) or known coronary artery disease - Signed informed consent (BASEC)
Critères d'exclusion
- Associated valvular heart disease or aortic dilation with indication for surgery or intervention - Unprotected left main coronary stenosis >50% based on coronary computed tomography angiography derived from a routine CT prior to TAVI - Left ventricular ejection fraction (LV-EF) < 30% - New regional wall motion abnormality on echocardiogram - Myocardial infarction within the last 12 months - Cardiac catheterization within the last 12 months - Previous stenting of the left main coronary artery (BASEC)
Lieu de l’étude
Berne
(BASEC)
Switzerland (ICTRP)
Sponsor
Insel Gruppe AG, Inselspital Bern, Universitätsklinik für Kardiologie
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Jonas Lanz
+41 31 632 21 11
jonas.lanz@clutterinsel.chInsel Gruppe AG, Inselspital Bern Universitätsklinik für Kardiologie
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
21.10.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06559332 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Randomized Controlled Trial of Coronary Artery Disease Assessment Strategies in Patients with Severe Aortic Stenosis undergoing Transcatheter Aortic Valve Implantation (CAT Trial) (BASEC)
Titre académique
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation (ICTRP)
Titre public
Coronary Artery Disease Assessment Strategies in TAVI Patients (ICTRP)
Maladie en cours d'investigation
Transcatheter Aortic Valve ReplacementCoronary Artery DiseaseHeart Disease Risk Factors (ICTRP)
Intervention étudiée
Diagnostic Test: Risk-based CAD managementDiagnostic Test: Invasive coronary angiography (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Inclusion:
Severe aortic stenosis defined by aortic valve area (AVA) =1cm2 AND mean gradient =40
mmHg or peak velocity =4.0 m/s
OR
if mean gradient <40 mmHg and peak velocity (Vmax) <4 m/s and stroke volume indexed to
body surface area (SVi) = 35 mL/m2 and LVEF =50% then if CT-derived aortic valve calcium
score >2000 Agatston units in men, >1200 in women
OR
if mean gradient <40 mmHg and Vmax <4 m/s and SVi = 35 mL/m2 and LVEF <50% then if
CT-derived aortic valve calcification >2000 Agatston units in men, >1200 in women OR if
low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke
volume) and AVA =1cm2
- Coronary calcium score = 400 Agatston units (derived from routine pre-TAVI CT) or
known coronary artery disease
- Selected for treatment with transfemoral TAVI.
- Written informed consent.
Exclusion Criteria:
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for
surgery or intervention
- Unprotected left main coronary stenosis >50% or left main not evaluable based on
coronary computed tomography angiography derived from routine pre-TAVI CT
- Left ventricular ejection fraction (LVEF) < 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
- Prior left main stenting (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization (ICTRP)
Patient reported health status;Patient reported health status;Patient reported health status;Rate of all cause death;Rate of cardiovascular death;Rate of disabling strokes;Rate of myocardial infarction;Rate of unplanned, urgent revascularization;Rate of elective revascularization;Rate of cardiovascular hospitalization;Rate of heart failure hospitalization;Rate of bleeding;Rate of acute kidney injury;Rate of tachyarrhythmia;Rate of major vascular complications;Rate of major cardiac structural complications;Rate of permanent pacemaker implantation (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Clinical Trials Unit Bern (CTU);Schweizerische Herzstiftung (ICTRP)
Contacts supplémentaires
Jonas Lanz, MD, MSc;Jonas Lanz, MD MSc;Jonas Lanz, MD, MSc, jonas.lanz@insel.ch, +41 31 632 21 11;, University of Bern, (ICTRP)
ID secondaires
CAT Trial (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06559332 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible