Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-02 @ 7:26 AM
Study NCT ID:
NCT05678868
Status:
UNKNOWN
Last Update Posted:
2023-01-10
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Structural Mitral Valve Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-22', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Electronic referral patient experience survey', 'timeFrame': 'At day one (study entry).', 'description': 'A survey of patient experience and satisfaction with the electronic referral method.\n\nComments:\n\nThe survey will be developed by the study investigator and each patient experience related question will be answered using the following scale: Strongly agree ☐ Agree ☐ Neither agree or disagree ☐ Disagree ☐ Strongly disagree. ☐ NA'}, {'measure': 'Electronic referral usage - eReferrals answered', 'timeFrame': 'At day one (study entry).', 'description': 'Proportion (%) of eReferral answered'}, {'measure': 'Electronic referral usage - response time', 'timeFrame': 'At day one (study entry).', 'description': 'median specialist response interval time (days).'}, {'measure': 'Electronic referral usage - inappropriate eReferrals', 'timeFrame': 'At day one (study entry).', 'description': 'proportion (%) of inappropriate eReferrals.'}, {'measure': 'Electronic referral usage - specialist time', 'timeFrame': 'At day one (study entry).', 'description': 'median time (hours) spent by specialist on eReferral.'}, {'measure': 'Cost comparison 1', 'timeFrame': 'At one day post procedure.', 'description': 'Cost comparison between eReferral and traditional referrals based on number of baseline (pre-procedural) lab tests and investigations.'}, {'measure': 'Cost comparison 2', 'timeFrame': 'On the day prior to procedure.', 'description': 'Cost comparison between eReferral and traditional referrals based on number of missed clinic visits.'}], 'primaryOutcomes': [{'measure': 'Wait time 1', 'timeFrame': 'At week three following study entry.', 'description': 'The time between date referral made and date acknowledged by cardiologist.'}, {'measure': 'Wait time 2', 'timeFrame': 'At week sixteen following study entry.', 'description': 'The time from acceptance for a procedure to time of pre-procedure imaging.'}, {'measure': 'Wait time 3', 'timeFrame': 'At week sixteen following study entry.', 'description': 'The time from acceptance for a procedure to time of procedure.'}], 'secondaryOutcomes': [{'measure': 'Morbidity 1', 'timeFrame': 'At 30 days post procedure.', 'description': 'Morbidity = all cause hospitalization and heart failure hospitalization post procedure.'}, {'measure': 'Morbidity 2', 'timeFrame': 'At one year post procedure.', 'description': 'Morbidity = all cause hospitalization and heart failure hospitalization post procedure.'}, {'measure': 'Mortality 1', 'timeFrame': 'At 30 days post procedure.', 'description': 'Mortality = all cause mortality'}, {'measure': 'Mortality 2', 'timeFrame': 'At one year post procedure.', 'description': 'Mortality = all cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': "This is a prospective Quality Improvement (QI) study using the Model for Improvement framework.\n\nThe objective of this study is to implement a structured, comprehensive, innovative, and sustainable approach to the management of patients with advanced mitral valve (MV) disease and heart failure (HF) in Southeastern Ontario and to improve healthcare delivery, patient care, and patient outcomes in the context of structural surgical and percutaneous MV interventions. This will be achieved through the strategic implementation, promotion, and evaluation of:\n\ni.The first local Southeastern Ontario Structural Mitral Valve Clinic using an Interdisciplinary heart team (IHT) at the Kingston Health Sciences Centre (KHSC) and its integration with the KHSC's existing Heart Failure Clinic; ii.The first provincial Structural Mitral Valve Clinic electronic referral service on the Ontario electronic services platform; and iii.The promotion of the above through targeted KT (Knowledge Transfer) outreach activities.\n\nPatients for this study will be recruited through medical referral within the south eastern Ontario, Canada region."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary and secondary moderate to severe MR with heart failure (HF) (preserved or reduced ejection fraction with New York Heart Association (NYHA) Class \\>II), who have had at least one previous hospitalization for HF, require specialist advisement.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll adults (≥18 years of age) patients with primary and secondary moderate to severe MR with HF (preserved or reduced ejection fraction with New York Heart Association (NYHA) Class \\>II), who have had at least one previous hospitalization for HR, require specialist advisement, and have provided signed informed consent.\n\nExclusion Criteria:\n\n* Those who are not eligible for either an MV surgical intervention or a TMVI procedure.\n* Females of childbearing age who are not willing or unable to use a reliable method of birth control.\n* Inpatient referrals.'}, 'identificationModule': {'nctId': 'NCT05678868', 'briefTitle': 'Structural Mitral Valve Project', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Implementation of a Structural Mitral Valve Clinic for the Management of Patients With Heart Failure Refractory to Medical Therapy', 'orgStudyIdInfo': {'id': 'Version Date January 25, 2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MitraClip procedure', 'type': 'PROCEDURE', 'description': 'MitraClip is surgical procedure to repair the mitral valve in your heart. During the procedure, the doctor will access the mitral valve using a thin tube (called a catheter) that is guided through a vein in your leg to reach your heart. A small implanted clip is attached to the mitral valve to reduce the leaking across the valve and to reduce symptoms and stress on the heart.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brigita Zile, RN, CCRP', 'role': 'CONTACT', 'email': 'bvz@queensu.ca', 'phone': '613-549-6666', 'phoneExt': '7109'}, {'name': 'Wael Abuzeid, MD', 'role': 'CONTACT', 'email': 'wael.abuzeid@queensu.ca', 'phone': '613-548-1381'}], 'facility': 'Kingston Health Sciences Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'centralContacts': [{'name': 'Brigita Zile, RN, CCRP', 'role': 'CONTACT', 'email': 'bvz@queensu.ca', 'phone': '613-549-6666', 'phoneExt': '7109'}, {'name': 'Wael Abuzeid, MD', 'role': 'CONTACT', 'email': 'wael.abuzeid@queensu.ca', 'phone': '613-548-1383'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'AFP Innovation Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, Interventional Cardiologist, Assistant Professor, Department of Medicine', 'investigatorFullName': 'Wael Abuzeid', 'investigatorAffiliation': "Queen's University"}}}}