Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT05374733
Status:
UNKNOWN
Last Update Posted:
2022-05-16
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The difference in the mean change in the FFR between the TAVI cohort and the TMVR cohort.', 'timeFrame': 'Baseline', 'description': 'The mean change in the FFR in TAVI patients will be compared to mean change in FFR in TMVr patients.'}, {'measure': 'The difference in the mean change in the RFR between the TAVI cohort and the TMVR cohort.', 'timeFrame': 'Baseline', 'description': 'The mean change in the RFR in TAVI patients will be compared to mean change in RFR in TMVr patients.'}, {'measure': 'The difference in the mean change in the dPR between the TAVI cohort and the TMVR cohort.', 'timeFrame': 'Baseline', 'description': 'The mean change in the dPR in TAVI patients will be compared to mean change in dPR in TMVr patients.'}, {'measure': 'The difference in the mean change in the Pd/Pa between the TAVI cohort and the TMVR cohort.', 'timeFrame': 'Baseline', 'description': 'The mean change in the Pd/Pa in TAVI patients will be compared to mean change in Pd/Pa in TMVr patients.'}, {'measure': 'The number of patients in who the post FFR, RFR, Pd/Pa or dPR value crosses the border of hemodynamic significance as compared to the value pre-valvular intervention.', 'timeFrame': 'Baseline', 'description': 'Number of patients who have 1) a positive FFR/RFR/Pd/Pa/dPR value pre-valvular intervention, and negative FFR/RFR/Pd/Pa/dPR post-valvular intervention or 2) a negative FFR/RFR/Pd/Pa/dPR pre-valvular intervention, and positive FFR/RFR/Pd/Pa/dPR value post-valvular intervention.'}, {'measure': 'The number of patients in whom the decision for coronary revascularization is altered when based on the post-procedural FFR value instead of angiographic stenosis severity.', 'timeFrame': 'Baseline', 'description': 'Number of patients who have 1) post-valvular intervention FFR ≤ 0.80 and diameter stenosis 50-70% or 2) post-valvular intervention FFR \\> 0.80 and diameter stenosis ≥ 70%.'}, {'measure': 'The diagnostic performance of vessel FFR (vFFR; an angiography-based FFR index) in the setting of valvular heart disease.', 'timeFrame': 'Baseline', 'description': 'The vFFR pre-intervention will be validated against the FFR-value both pre- and post-intervention'}], 'primaryOutcomes': [{'measure': 'The change in the FFR value before and after TAVI', 'timeFrame': 'Directly before and after the TAVI procedure (1 hour)', 'description': 'The impact of TAVI on FFR'}, {'measure': 'The change in the FFR value before and after TMVr', 'timeFrame': 'Directly before and after the TMVr procedure (1 hour)', 'description': 'The impact of TMVr on FFR'}], 'secondaryOutcomes': [{'measure': 'The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on RFR'}, {'measure': 'The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on dPR'}, {'measure': 'The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on Pd/Pa'}, {'measure': 'The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on CFR'}, {'measure': 'The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on IMR'}, {'measure': 'The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on the transvalvular gradient'}, {'measure': 'The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on the LVEDP'}, {'measure': 'The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on hemodynamics'}, {'measure': 'The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)', 'timeFrame': 'Directly before and after the TAVI/TMVr procedure (1 hour)', 'description': 'The impact of TAVI/TMVr on hemodynamics'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Coronary Physiology'], 'conditions': ['Aortic Valve Stenosis', 'Mitral Regurgitation', 'Coronary Artery Disease', 'Fractional Flow Reserve']}, 'descriptionModule': {'briefSummary': 'Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.', 'detailedDescription': "The POTUS study is a prospective, investigator-initiated, single-arm observational study with invasive measurements that will consist of two cohorts. The first cohort consists of 120 patients with intermediate coronary artery disease who undergo a transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis ('TAVI cohort'). The second cohort consists of 30 patients with intermediate coronary artery disease who undergo transcatheter mitral valve repair (TMVr) for functional/degenerative mitral regurgitation ('TMVr cohort'). Both cohorts will undergo a battery of coronary physiological tests both before and after the valvular intervention. Additionally, in the case that the fractional flow reserve (FFR) over a coronary lesion is significant (i.e. FFR ≤ 0.80) during the post valvular intervention measurements, additional percutaneous coronary intervention (PCI) will take place during the same procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18.\n* a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team.\n\n b) TMVr cohort: severe functional/degenerative mitral regurgitation for which TMVr is scheduled after discussion in the Heart Team.\n* At least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel ≥ 2.5 mm\n* Elective procedure\n* Written informed consent\n\nExclusion Criteria:\n\n* TAVI cohort: height coronary ostia \\< 10 mm\n* Severe chronic kidney disease, defined as estimated glomerular filtration rate \\< 30 ml/min.\n* Contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine.\n* Degenerated surgical or transcatheter aortic valve bioprosthesis.\n* Vessels that have collaterals to a chronic total occlusion or that are supplied by an arterial or venous bypass graft will not be interrogated in this study.'}, 'identificationModule': {'nctId': 'NCT05374733', 'acronym': 'POTUS', 'briefTitle': 'Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation', 'orgStudyIdInfo': {'id': 'POTUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm', 'description': 'Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention.', 'interventionNames': ['Diagnostic Test: Coronary Physiology assessment']}], 'interventions': [{'name': 'Coronary Physiology assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Pd/Pa, diastolic pressure ratio (dPR), resting full cycle ratio (RFR), FFR, coronary flow reserve (CFR), and index of microvascular resistance (IMR) measurements in the coronary of interest before the valvular intervention.\n2. Pd/Pa, dPR, RFR, FFR, vFFR, CFR and IMR measurements in the coronary of interest after the valvular intervention.', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Nicolas M van Mieghem, MD, PhD', 'role': 'CONTACT', 'email': 'n.vanmieghem@erasmusmc.nl', 'phone': '+31(0)107035260'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Nicolas M van Mieghem, MD, PhD', 'role': 'CONTACT', 'email': 'n.vanmieghem@erasmusmc.nl', 'phone': '+31 (0)10 70 352 60'}], 'overallOfficials': [{'name': 'Nicolas M van Mieghem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Nicolas M. Van Mieghem', 'investigatorFullName': 'Nicolas van Mieghem', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}