protocolSection identificationModule nctId: NCT06322017, orgStudyIdInfo id: RC22_0450, briefTitle: Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation, acronym: EDearly AF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2028-04-09, completionDateStruct date: 2028-04-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Therapeutic management of Atrial Fibrillation (AF) is based either on heart rate control or on rhythm control, a strategy which aims to maintain a normal heart rhythm. The benefit in terms of morbidity and mortality of a normal heart rhythm would, however, be largely offset by the frequent side effects of antiarrhythmic drugs which could even lead to an increase in mortality compared to rate control. This increase has particularly been suggested in people aged over 75.Since the emergence of catheter Pulmonary Vein Isolation (PVI), an effective alternative to antiarrhythmic drugs has become available. This technique makes it possible to isolate the foci triggering AF under local or general anesthesia with greater effectiveness than medications and very low risks. Records in the elderly do not seem to show a reduction in effectiveness or an increase in complications. However, in the absence of a dedicated randomized study, its use is strongly limited in the elderly where rate control (52% of people over 65 years old) and the use of antiarrhythmic drugs are largely favored due to the simplicity of implementation and the low cost of medications.However, an early rhythm control strategy seems to reduce cardiovascular events in relatively old individuals (average age 70 years). The use of PVI in first line could make it possible to further improve these results.The objective of the investigator is therefore to carry out the first randomized comparative study proposing to evaluate the impact of early PVI compared to usual treatment in patients aged 75 and over with AF., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 294, type: ESTIMATED, armsInterventionsModule interventions name: Rhythm control by Pulmonary Vein Isolation (PVI) procedure, interventions name: Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin), outcomesModule primaryOutcomes measure: Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke, secondaryOutcomes measure: Number of PVI peri-procedural complications, secondaryOutcomes measure: Number of complications, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Number of documented episodes of AF, secondaryOutcomes measure: Number of patients treated by cardiovascular drugs, secondaryOutcomes measure: Doses of cardiovascular drugs, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Physical performance score, secondaryOutcomes measure: Physical performance score, secondaryOutcomes measure: Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion, secondaryOutcomes measure: Evolution of IADL score according to the results of the ICOPE test at inclusion, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, status: RECRUITING, city: Nantes, state: Loire Atlantique, zip: 44093, country: France, contacts name: Jean-Baptiste GOURRAUD, MD, role: CONTACT, phone: 0240165143, email: JeanBaptiste.GOURRAUD@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False