Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Pulmonary vein isolation, Elderly Conventional management, Frailty
Brief summary
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.
Interventions
PROCEDURERhythm control by Pulmonary Vein Isolation (PVI) procedure
The PVI procedure involves the creation of a circumferential lesion around the ostium of the four pulmonary veins. The choice of the type of energy to insure the lesion will be left to the discretion of the investigator, according to the center's habits and the patient's anatomy found on the scanner.
DRUGConventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin)
Ventricular rate control is carried out using negative chronotropic agents (e.g. beta-blockers, calcium channel blockers, digitalis, etc.) according to current recommendations. If this fails, ablation of the atrioventricular junction with placement of a permanent pacemaker can be carried out according to current recommendations. As part of this research, the choice of bradycardic drugs and interventions will be left to the discretion of the investigator according to the center's practices and current recommendations. Rhythm control aims to reduce AF by cardioversion (if it persists) to restore sinus rhythm and subsequently maintain it by introducing anti-arrhythmic treatment. Several antiarrhythmic drugs (flecainide, sotalol or amiodarone) can be used in this setting. As part of this research, the choice of antiarrhythmic drugs will be left to the discretion of the investigator according to the center's practices and current recommendations.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man or woman aged 75 and over. * Paroxysmal AF or early recurrent or persistent paroxysmal AF first diagnosed less than 12 months ago. * Patient who consented to participate in the study. * Patient affiliated to a social security system.
Exclusion criteria
* Indication of cardiac pacing or defibrillation at baseline. * History of valve replacement, atrial occlusion or exclusion. * History of AF ablation. * Contraindication to anticoagulation or an invasive procedure. * Significant heart disease (structural with alteration of LVEF \<35%, congenital heart disease, hypertrophic heart disease with wall of more than 15 mm, revascularized coronary syndrome less than 3 months old). * Stroke less than 6 months old. * Uncontrolled dysthyroidism. * Chronic renal failure (CKD - eGFR \<30 µMol/L). * Patient under curatorship, guardianship, safeguard of justice. * Life expectancy less than 24 months. * Participation in another therapeutic trial likely to impact the study evaluation criteria. * Severe cognitive impairment noted in history. * Lack of understanding of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke | 2 years | Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | Inclusion | EQ-5D-5L score |
| Number of documented episodes of AF | 2 years | — |
| Number of patients treated by cardiovascular drugs | 2 years | — |
| Doses of cardiovascular drugs | 2 years | milligrams |
| Autonomy score | Inclusion | Activities of Daily Living (ADL) score |
| Body weight | Inclusion | kilograms |
| Number of complications | 2 years | — |
| Number of PVI peri-procedural complications | 48 hours | — |
| Physical performance score | Inclusion | Short Physical Performance Battery (SPPB) test score |
| Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion | 2 years | — |
| Evolution of IADL score according to the results of the ICOPE test at inclusion | 2 years | — |
| Cognitive assessment | Inclusion | Mini-Mental State Examination (MMSE) score |
| Numbers of falls | Inclusion | — |
Countries
France
Contacts
Primary ContactJean-Baptiste Gourraud, MD
Outcome results
None listed