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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
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.
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.
Nantes University Hospital
Nantes, Loire Atlantique, France
RECRUITINGTime before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke
Days
Time frame: 2 years
Number of PVI peri-procedural complications
Time frame: 48 hours
Number of complications
Time frame: 2 years
Quality of life score
EQ-5D-5L score
Time frame: Inclusion
Quality of life score
EQ-5D-5L score
Time frame: 3 months
Quality of life score
EQ-5D-5L score
Time frame: 6 months
Quality of life score
EQ-5D-5L score
Time frame: 12 months
Quality of life score
EQ-5D-5L score
Time frame: 18 months
Quality of life score
EQ-5D-5L score
Time frame: 24 months
Number of documented episodes of AF
Time frame: 2 years
Number of patients treated by cardiovascular drugs
Time frame: 2 years
Doses of cardiovascular drugs
milligrams
Time frame: 2 years
Autonomy score
Activities of Daily Living (ADL) score
Time frame: Inclusion
Autonomy score
ADL score
Time frame: 3 months
Autonomy score
ADL score
Time frame: 6 months
Autonomy score
ADL score
Time frame: 12 months
Autonomy score
ADL score
Time frame: 18 months
Autonomy score
ADL score
Time frame: 24 months
Autonomy score
Instrumental Activities of Daily Living (IADL) score
Time frame: Inclusion
Autonomy score
IADL score
Time frame: 3 months
Autonomy score
IADL score
Time frame: 6 months
Autonomy score
IADL score
Time frame: 12 months
Autonomy score
IADL score
Time frame: 18 months
Autonomy score
IADL score
Time frame: 24 months
Body weight
kilograms
Time frame: Inclusion
Body weight
kilograms
Time frame: 3 months
Body weight
kilograms
Time frame: 6 months
Body weight
kilograms
Time frame: 12 months
Body weight
kilograms
Time frame: 18 months
Body weight
kilograms
Time frame: 24 months
Numbers of falls
Time frame: Inclusion
Numbers of falls
Time frame: 3 months
Numbers of falls
Time frame: 6 months
Numbers of falls
Time frame: 12 months
Numbers of falls
Time frame: 18 months
Numbers of falls
Time frame: 24 months
Physical performance score
Short Physical Performance Battery (SPPB) test score
Time frame: Inclusion
Physical performance score
SPPB test score
Time frame: 2 years
Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion
Time frame: 2 years
Evolution of IADL score according to the results of the ICOPE test at inclusion
Time frame: 2 years
Cognitive assessment
Mini-Mental State Examination (MMSE) score
Time frame: Inclusion
Cognitive assessment
MMSE score
Time frame: 2 years
Cognitive assessment
Batterie Rapide d'Efficience Frontale (BREF) score
Time frame: Inclusion
Cognitive assessment
BREF score
Time frame: 2 years
Cognitive assessment
Mini Geriatric Depression Scale (GDS) score
Time frame: Inclusion
Cognitive assessment
Mini GDS score
Time frame: 2 years
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