Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT06758895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-06
First Post:
2024-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-28', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-28', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurence in patient with AF or flutter after pharmacological or interventional rythm control', 'timeFrame': 'Baseline', 'description': '* Non-invasive rhythm control arm: Predictors of atrial fibrillation recurrence within 6 months of cardioversion or the need for ≥2 cardioversions in the 1st year after initial cardioversion.\n* Ablation arm: Predictors of success rate (acute and mid term) of ablation on multivariable logistic regression analysis.'}], 'secondaryOutcomes': [{'measure': 'parameters for safe ablation', 'timeFrame': 'Baseline', 'description': '* Ablation arm: Predictors of esophageal thermal injury (ETI).\n* Arterial embolic events in both arms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CMR predictors of rhythm control in patient with AFibirilation/flutter'], 'conditions': ['Rhythm Monitoring']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Calkins H et al. Circ Arrhythm Electrophysiol. 2009'}]}, 'descriptionModule': {'briefSummary': 'evaluate the impact of various features in CMR on the mid-term/long-term success rate of rhythm control for paroxysmal atrial fibrillation/flutter .', 'detailedDescription': '* Atrial fibrillation/flutter are widely prevalent.\n* Reported antiarrhythmic drug efficacy to restore \\& maintain sinus rhythm is 52% which is far from optimal.\n* On the other hand, 5-year arrhythmia-free survival after catheter ablation was previously reported to be 63%.\n* Therefore, there is a need for better characterization of the underlying atrial substrate, to improve treatment outcomes in terms of efficacy and safety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Based on the previously reported antiarrhythmic drug efficacy of 52% in maintaining sinus rhythm:\n\n* For Wilcoxon-Mann-Whitney test for difference in 2 group means: assuming an alpha error probability of 0.05, a study power of 60-70%, and a 1:1 ratio of successful rhythm control vs atrial fibrillation/flutter recurrence, a total sample size of 86-106 would be needed (43-53 for each arm). \\[calculated by G\\*Power software v.3.1.9.7\\]\n* To be able to build multivariable logistic regression models including, e.g., 4-5 predictor variables, a reasonable sample size would be 80-100 patients.\n* Patient enrollment will continue until the projected sample size is satisfied or until 24 months have lapsed, whichever comes first.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years.\n* Patients undergoing successful cardioversion (pharmacologic or electric) for atrial fibrillation/flutter, OR symptomatic patients with paroxysmal atrial fibrillation/flutter scheduled for trans-catheter ablation.\n* Index cardioversion OR Index ablation procedure.\n\nExclusion Criteria:\n\n* LA thrombus on TEE or CMR.\n* Contraindications to CMR.\n* Contraindications to Gd-based contrast.'}, 'identificationModule': {'nctId': 'NCT06758895', 'briefTitle': 'Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter', 'orgStudyIdInfo': {'id': 'CMR in rythm control'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut Univeristy Heart Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Maryem Ashraf Abd El-Naeem Sayed, Resident Doctor', 'role': 'CONTACT', 'email': 'reemy.rooma77@gmail.com', 'phone': '+2001097400995'}, {'name': 'Amr EL-Badry Ibrahim, Lecture of cardiology', 'role': 'CONTACT', 'email': 'aelbadry@aun.edu.eg', 'phone': '+2001060701601'}], 'overallOfficials': [{'name': 'Salah EL-dein Sayed Ata, Professor of cardiology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor at Assiut University Heart Hospital', 'investigatorFullName': 'Maryam Ashraf Abd El-Naeem Sayed', 'investigatorAffiliation': 'Assiut University'}}}}