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

Atrial Fibrillation Clinical Trial

— EDearly AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322017
• Other study ID #: RC22_0450
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: April 9, 2028

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Jean-Baptiste Gourraud, MD
• Phone: 0240165143
• Email: JeanBaptiste.GOURRAUD[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: April 9, 2028
• Est. primary completion date: April 9, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Rhythm 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.

Drug:
• Conventional 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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke	Days	2 years
Secondary	Number of PVI peri-procedural complications		48 hours
Secondary	Number of complications		2 years
Secondary	Quality of life score	EQ-5D-5L score	Inclusion
Secondary	Quality of life score	EQ-5D-5L score	3 months
Secondary	Quality of life score	EQ-5D-5L score	6 months
Secondary	Quality of life score	EQ-5D-5L score	12 months
Secondary	Quality of life score	EQ-5D-5L score	18 months
Secondary	Quality of life score	EQ-5D-5L score	24 months
Secondary	Number of documented episodes of AF		2 years
Secondary	Number of patients treated by cardiovascular drugs		2 years
Secondary	Doses of cardiovascular drugs	milligrams	2 years
Secondary	Autonomy score	Activities of Daily Living (ADL) score	Inclusion
Secondary	Autonomy score	ADL score	3 months
Secondary	Autonomy score	ADL score	6 months
Secondary	Autonomy score	ADL score	12 months
Secondary	Autonomy score	ADL score	18 months
Secondary	Autonomy score	ADL score	24 months
Secondary	Autonomy score	Instrumental Activities of Daily Living (IADL) score	Inclusion
Secondary	Autonomy score	IADL score	3 months
Secondary	Autonomy score	IADL score	6 months
Secondary	Autonomy score	IADL score	12 months
Secondary	Autonomy score	IADL score	18 months
Secondary	Autonomy score	IADL score	24 months
Secondary	Body weight	kilograms	Inclusion
Secondary	Body weight	kilograms	3 months
Secondary	Body weight	kilograms	6 months
Secondary	Body weight	kilograms	12 months
Secondary	Body weight	kilograms	18 months
Secondary	Body weight	kilograms	24 months
Secondary	Numbers of falls		Inclusion
Secondary	Numbers of falls		3 months
Secondary	Numbers of falls		6 months
Secondary	Numbers of falls		12 months
Secondary	Numbers of falls		18 months
Secondary	Numbers of falls		24 months
Secondary	Physical performance score	Short Physical Performance Battery (SPPB) test score	Inclusion
Secondary	Physical performance score	SPPB test score	2 years
Secondary	Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion		2 years
Secondary	Evolution of IADL score according to the results of the ICOPE test at inclusion		2 years
Secondary	Cognitive assessment	Mini-Mental State Examination (MMSE) score	Inclusion
Secondary	Cognitive assessment	MMSE score	2 years
Secondary	Cognitive assessment	Batterie Rapide d'Efficience Frontale (BREF) score	Inclusion
Secondary	Cognitive assessment	BREF score	2 years
Secondary	Cognitive assessment	Mini Geriatric Depression Scale (GDS) score	Inclusion
Secondary	Cognitive assessment	Mini GDS score	2 years