Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-22 @ 10:59 AM
Study NCT ID:
NCT06255457
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D008945', 'term': 'Mitral Valve Prolapse'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016127', 'term': 'Heart Valve Prolapse'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-02-04', 'studyFirstSubmitQcDate': '2024-02-04', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular arrhythmias', 'timeFrame': '6 months', 'description': 'Change in ventricular arrhythmic burden (composite of non-sustained or sustained ventricular tachycardias, ventricular fibrillation or premature ventricular complexes)'}, {'measure': 'Extracellular volume', 'timeFrame': '6 months', 'description': 'Change in indexed extracellular volume as surrogate marker for diffuse reversible fibrosis measured by CMR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Regurgitation', 'Mitral Valve Prolapse', 'Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'Study objectives:\n\n* To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery\n* To characterize the molecular landscape of arrhytmogenic MVP\n\nStudy design:\n\n-Prospective explorative observational study\n\nStudy population:\n\n-90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery', 'detailedDescription': 'Prospective explorative observational study in which the impact of mitral valve surgery for mitral regurgitation on ventricular arrhytmias and CMR imaging biomarkers will be examined in patients with arrhythmogenic MVP compared to those without arrhythmogenic MVP (controls). Molecular phenotyping of endocardial biopsies in patients with and without arrhythmogenic MVP will be performed as well as molecular phenotyping of the myxomatous disease in explanted valves by means of deep RNA single cell sequencing. Using CMR in 90 patients with MVP before and 6 months after mitral valve surgery, the presence and type (reversible vs irreversible) of papillary muscle and cardiac fibrosis will be characterized. To assess change in ventricular arrhytmic burden after surgery, patients will undergo continuous seven day monitoring with E-patch at baseline and at 6 months after mitral valve surgery. During surgery, explanted mitral valves (in patients undergoing replacement) as well as endocardial biopsies will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with and without arrhythmogenic MVP with primary mitral regurgitation eligible for mitral valve surgery according to current standard of care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age 18 and over\n* Patients with and without (controls) arrhythmogenic MVP in need of mitral valve surgery for primary mitral regurgitation according to current standard of care\n\nExclusion criteria\n\n* Secondary mitral regurgitation\n* Primary mitral regurgitation not due to degenerative disease (including rheumatic disease)\n* Co-existing moderate or severe aortic valve disease\n* Congenital heart disease\n* Inherited or acquired cardiomyopathy\n* Non-incidental or symptomatic coronary artery disease\n* Uncontrolled atrial fibrillation (resting heart rate \\> 100/min)\n* Pregnancy\n* Unable to undergo CMR'}, 'identificationModule': {'nctId': 'NCT06255457', 'acronym': 'Mitra-VT', 'briefTitle': 'Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery', 'orgStudyIdInfo': {'id': 'VR 2022-01472'}, 'secondaryIdInfos': [{'id': 'SG-23-0142-B', 'type': 'OTHER_GRANT', 'domain': 'Svenska Sällskapet för Medicinsk Forskning (SSMF)'}, {'id': '987010', 'type': 'OTHER_GRANT', 'domain': 'Svenska Läkaresällskapet (SLS)'}, {'id': '20220524', 'type': 'OTHER_GRANT', 'domain': 'Hjärtlungfonden (HLF)'}, {'id': '2-116/2023', 'type': 'OTHER_GRANT', 'domain': 'karolinska Institutet'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse', 'description': 'Surgical repair or replacement of the mitral valve due to significant mitral regurgitation according to standard of care.', 'interventionNames': ['Procedure: Mitral valve surgery']}], 'interventions': [{'name': 'Mitral valve surgery', 'type': 'PROCEDURE', 'description': 'Mitral valve repair or replacement of mitral regurgitation', 'armGroupLabels': ['Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 76', 'city': 'Stockholm', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Bahira Shahim, MD, PhD', 'role': 'CONTACT', 'email': 'bahira.shahim@ki.se', 'phone': '+46705347350'}, {'name': 'Bahira Shahim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karolinska Univeristy Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Bahira Shahim', 'investigatorAffiliation': 'Karolinska Institutet'}}}}