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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhythm control by Pulmonary Vein Isolation (PVI) procedure | Experimental |
| |
| Conventional care by antiarrhythmic drugs or bradycardic drugs | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythm control by Pulmonary Vein Isolation (PVI) procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke | Days | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of PVI peri-procedural complications | 48 hours | |
| Number of complications | 2 years | |
| Quality of life score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Baptiste Gourraud, MD | Contact | 0240165143 | JeanBaptiste.GOURRAUD@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Baptiste Gourraud, MD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Recruiting | Nantes | Loire Atlantique | 44093 | France |
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| Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin) | Drug | 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. |
|
EQ-5D-5L score |
| Inclusion |
| Quality of life score | EQ-5D-5L score | 3 months |
| Quality of life score | EQ-5D-5L score | 6 months |
| Quality of life score | EQ-5D-5L score | 12 months |
| Quality of life score | EQ-5D-5L score | 18 months |
| Quality of life score | EQ-5D-5L score | 24 months |
| Number of documented episodes of AF | 2 years |
| Number of patients treated by cardiovascular drugs | 2 years |
| Doses of cardiovascular drugs | milligrams | 2 years |
| Autonomy score | Activities of Daily Living (ADL) score | Inclusion |
| Autonomy score | ADL score | 3 months |
| Autonomy score | ADL score | 6 months |
| Autonomy score | ADL score | 12 months |
| Autonomy score | ADL score | 18 months |
| Autonomy score | ADL score | 24 months |
| Autonomy score | Instrumental Activities of Daily Living (IADL) score | Inclusion |
| Autonomy score | IADL score | 3 months |
| Autonomy score | IADL score | 6 months |
| Autonomy score | IADL score | 12 months |
| Autonomy score | IADL score | 18 months |
| Autonomy score | IADL score | 24 months |
| Body weight | kilograms | Inclusion |
| Body weight | kilograms | 3 months |
| Body weight | kilograms | 6 months |
| Body weight | kilograms | 12 months |
| Body weight | kilograms | 18 months |
| Body weight | kilograms | 24 months |
| Numbers of falls | Inclusion |
| Numbers of falls | 3 months |
| Numbers of falls | 6 months |
| Numbers of falls | 12 months |
| Numbers of falls | 18 months |
| Numbers of falls | 24 months |
| Physical performance score | Short Physical Performance Battery (SPPB) test score | Inclusion |
| Physical performance score | SPPB test score | 2 years |
| 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 | Mini-Mental State Examination (MMSE) score | Inclusion |
| Cognitive assessment | MMSE score | 2 years |
| Cognitive assessment | Batterie Rapide d'Efficience Frontale (BREF) score | Inclusion |
| Cognitive assessment | BREF score | 2 years |
| Cognitive assessment | Mini Geriatric Depression Scale (GDS) score | Inclusion |
| Cognitive assessment | Mini GDS score | 2 years |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| D013015 | Sotalol |
| D000638 | Amiodarone |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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