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

NCT ID: NCT06322017

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2030-04-09

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rhythm control by Pulmonary Vein Isolation (PVI) procedure

Group Type: EXPERIMENTAL

Rhythm control by Pulmonary Vein Isolation (PVI) procedure

Intervention Type: 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.

Conventional care by antiarrhythmic drugs or bradycardic drugs

Group Type: ACTIVE_COMPARATOR

Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Baptiste Gourraud, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, Loire Atlantique, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Baptiste Gourraud, MD

Role: CONTACT

JeanBaptiste.GOURRAUD@chu-nantes.fr

0240165143

Facility Contacts

Jean-Baptiste GOURRAUD, MD

Role: primary

JeanBaptiste.GOURRAUD@chu-nantes.fr

0240165143

Other Identifiers

RC22_0450

Identifier Type: -

Identifier Source: org_study_id