Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT06559332
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2024-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Artery Disease Assessment Strategies in TAVI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Clinical event adjudication committee will be blinded to group allocation.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 546}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2032-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization', 'timeFrame': '3 years', 'description': 'Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)'}], 'secondaryOutcomes': [{'measure': 'Patient reported health status', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': 'Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health)'}, {'measure': 'Patient reported health status', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': 'Kansas City Cardiomyopathy Questionnaire-12 (score from 0 to 100, with higher values indicating better health)'}, {'measure': 'Patient reported health status', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': 'EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health)'}, {'measure': 'Rate of all cause death', 'timeFrame': '3 months, 1, 3 and 5 years'}, {'measure': 'Rate of cardiovascular death', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of disabling strokes', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of myocardial infarction', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of unplanned, urgent revascularization', 'timeFrame': '3 months, 1, 3 and 5 years'}, {'measure': 'Rate of elective revascularization', 'timeFrame': '3 months, 1, 3 and 5 years'}, {'measure': 'Rate of cardiovascular hospitalization', 'timeFrame': '3 months, 1, 3 and 5 years'}, {'measure': 'Rate of heart failure hospitalization', 'timeFrame': '3 months, 1, 3 and 5 years'}, {'measure': 'Rate of bleeding', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of acute kidney injury', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of tachyarrhythmia', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of major vascular complications', 'timeFrame': '3months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of major cardiac structural complications', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}, {'measure': 'Rate of permanent pacemaker implantation', 'timeFrame': '3 months, 1, 3 and 5 years', 'description': '(VARC-3)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transcatheter Aortic Valve Replacement', 'Coronary Artery Disease', 'Heart Disease Risk Factors']}, 'descriptionModule': {'briefSummary': 'Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.\n\nAs the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear.\n\nThe CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n• Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s\n\nOR\n\nif 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\n\nOR\n\nif 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\n\n* Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease\n* Selected for treatment with transfemoral TAVI.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention\n* Unprotected left main coronary stenosis \\>50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT\n* Left ventricular ejection fraction (LVEF) \\< 30%\n* New regional wall motion abnormalities on echocardiography\n* Myocardial infarction in previous 12 months\n* Coronary angiography in previous 12 months\n* Prior left main stenting'}, 'identificationModule': {'nctId': 'NCT06559332', 'acronym': 'CAT', 'briefTitle': 'Coronary Artery Disease Assessment Strategies in TAVI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation', 'orgStudyIdInfo': {'id': 'CAT Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risk-based management strategy without invasive coronary angiography', 'description': 'Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.', 'interventionNames': ['Diagnostic Test: Risk-based CAD management']}, {'type': 'OTHER', 'label': 'Routine invasive coronary angiography', 'description': "Routine invasive coronary angiography prior to TAVI. Percutaneous coronary intervention (PCI) recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.", 'interventionNames': ['Diagnostic Test: Invasive coronary angiography']}], 'interventions': [{'name': 'Risk-based CAD management', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.', 'armGroupLabels': ['Risk-based management strategy without invasive coronary angiography']}, {'name': 'Invasive coronary angiography', 'type': 'DIAGNOSTIC_TEST', 'description': "Routine invasive coronary angiography prior to TAVI. PCI recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.", 'armGroupLabels': ['Routine invasive coronary angiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Jonas Lanz, MD, MSc', 'role': 'CONTACT'}], 'facility': 'University Hospital Bern, Department of Cardiology', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Jonas Lanz, MD MSc', 'role': 'CONTACT', 'email': 'jonas.lanz@insel.ch', 'phone': '+41 31 632 21 11'}, {'name': 'Thomas Pilgrim, MD MPH', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Jonas Lanz, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'after study completion', 'ipdSharing': 'YES', 'description': 'sharing via https://boris.unibe.ch platform', 'accessCriteria': 'Data will be made available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Trials Unit Bern (CTU)', 'class': 'UNKNOWN'}, {'name': 'Schweizerische Herzstiftung', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}