Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:37 PM
Study NCT ID:
NCT07454135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Atrial Pathoelectrophysiology in HCM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in electrophysiological properties of the atria in patients with HCM and AF compared to patients with AF and structurally normal hearts', 'timeFrame': 'At the time of the clinical ablation procedure'}], 'secondaryOutcomes': [{'measure': 'Correlatation between the electrophysiological changes in the atria with directly measured left atrial pressure, extent of late gadolinium enhancement and ventricular extracellular volume .', 'timeFrame': 'At the time of clinical ablation procedure'}, {'measure': 'Response to various ablation strategies applied in patient specific computational models.', 'timeFrame': 'Based on measurements taken during the clinical ablation procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertrophic cardiomyopathy', 'atrial fibrillation'], 'conditions': ['Hypertrophic Cardiomyopathy (HCM)', 'Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'This study aims to learn why atrial fibrillation (AF), a type of irregular heartbeat, happens more often and is harder to treat in people with hypertrophic cardiomyopathy (HCM). HCM is an inherited condition where the heart muscle is thicker than usual.\n\nResearchers will study electrical signals from the heart and advanced heart imaging. By doing this, they hope to better understand how AF behaves in people with HCM and why treatments may not work as well for them.\n\nThe information from this study may help improve future treatments for people who have both HCM and AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hypertrophic cardiomyopathy and atrial fibrillation requiring atrial fibrillation ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paroxysmal or persistent atrial fibrillation\n* Diagnosis of hypertrophic cardiomyopathy\n* Patient planning to proceed to atrial fibrillation ablation following clinical consultation\n* Age 18-80 years\n* Able and willing to provide written informed consent\n* Able and willing to comply with study follow up requirements\n\nExclusion Criteria:\n\n* Any clinical contra-indication to ablation\n* Any disease limiting life expectancy to \\<1 year\n* Potential participant currently pregnant or breast feeding\n* Contraindication to MRI including renal dysfunction (eGFR\\<30ml/min)\n* Unable to understand verbal or written explanations given in English'}, 'identificationModule': {'nctId': 'NCT07454135', 'acronym': 'MAP HCM', 'briefTitle': 'Mechanisms of Atrial Pathoelectrophysiology in HCM', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Mechanisms of Atrial Pathoelectrophysiology in HCM', 'orgStudyIdInfo': {'id': '339394'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with HCM and AF'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Magdalena Klis', 'role': 'CONTACT', 'email': 'magda.klis@kcl.ac.uk', 'phone': '02071887188'}], 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}