protocolSection identificationModule nctId: NCT06299514, orgStudyIdInfo id: 4754, briefTitle: RAFT-P&A Randomized Control Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy., conditionsModule conditions: Atrial Fibrillation, conditions: Heart Failure, conditions: Pacemaker, conditions: Arrhythmia Atrial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Pace and Ablate, interventions name: Medication, outcomesModule primaryOutcomes measure: Winratio, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Cardiovascular mortality, secondaryOutcomes measure: Number of heart failure events, secondaryOutcomes measure: All-cause hospitalization, secondaryOutcomes measure: Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ), secondaryOutcomes measure: Exercise, secondaryOutcomes measure: Biochemical marker, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Sciences Centre - University Hospital, city: London, state: Ontario, zip: N6A5A5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: London Health Sciences Research, city: London, state: Ontario, zip: N6G5A5, country: Canada, contacts name: Abbie Pardo, role: CONTACT, phone: 5196612111, phoneExt: 86459, email: abbie.pardo@lhsc.on.ca, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False