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

NCT06322017 | Recruiting

• 1 other identifier: RC22_0450
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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

Keywords

Atrial fibrillation; Pulmonary vein isolation; Elderly Conventional management; Frailty

Outcome Measures

Primary Outcomes (1)

• Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke

  Days

  2 years

Secondary Outcomes (45)

• Number of PVI peri-procedural complications

  48 hours

• Number of complications

  2 years

• Quality of life score

  Inclusion

• Quality of life score

  3 months

• Quality of life score

  6 months

Study Arms (2)

Rhythm control by Pulmonary Vein Isolation (PVI) procedure

EXPERIMENTAL

Procedure: Rhythm control by Pulmonary Vein Isolation (PVI) procedure

Conventional care by antiarrhythmic drugs or bradycardic drugs

ACTIVE COMPARATOR

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

Interventions

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.

Rhythm control by Pulmonary Vein Isolation (PVI) procedure

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.

Conventional care by antiarrhythmic drugs or bradycardic drugs

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Indication of cardiac pacing or defibrillation at baseline.
• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire Atlantique, 44093, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Frailty

Interventions

Flecainide; Sotalol; Amiodarone; Digoxin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Jean-Baptiste Gourraud, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Baptiste Gourraud, MD

CONTACT

0240165143; JeanBaptiste.GOURRAUD@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 20, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): April 9, 2030
• Study Completion (Estimated): April 9, 2030
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)