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NCT Number: NCT06322017

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

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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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, Loire Atlantique, 44093, France

Location status: Recruiting

Location contact

Jean-Baptiste GOURRAUD, MD

CONTACT

[email protected]

0240165143

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 2 years

    Days

Secondary outcomes

  1. Number of PVI peri-procedural complications

    Time frame: 48 hours

  2. Number of complications

    Time frame: 2 years

  3. Quality of life score

    Time frame: Inclusion

    EQ-5D-5L score

  4. Quality of life score

    Time frame: 3 months

    EQ-5D-5L score

  5. Quality of life score

    Time frame: 6 months

    EQ-5D-5L score

  6. Quality of life score

    Time frame: 12 months

    EQ-5D-5L score

  7. Quality of life score

    Time frame: 18 months

    EQ-5D-5L score

  8. Quality of life score

    Time frame: 24 months

    EQ-5D-5L score

  9. Number of documented episodes of AF

    Time frame: 2 years

  10. Number of patients treated by cardiovascular drugs

    Time frame: 2 years

  11. Doses of cardiovascular drugs

    Time frame: 2 years

    milligrams

  12. Autonomy score

    Time frame: Inclusion

    Activities of Daily Living (ADL) score

  13. Autonomy score

    Time frame: 3 months

    ADL score

  14. Autonomy score

    Time frame: 6 months

    ADL score

  15. Autonomy score

    Time frame: 12 months

    ADL score

  16. Autonomy score

    Time frame: 18 months

    ADL score

  17. Autonomy score

    Time frame: 24 months

    ADL score

  18. Autonomy score

    Time frame: Inclusion

    Instrumental Activities of Daily Living (IADL) score

  19. Autonomy score

    Time frame: 3 months

    IADL score

  20. Autonomy score

    Time frame: 6 months

    IADL score

  21. Autonomy score

    Time frame: 12 months

    IADL score

  22. Autonomy score

    Time frame: 18 months

    IADL score

  23. Autonomy score

    Time frame: 24 months

    IADL score

  24. Body weight

    Time frame: Inclusion

    kilograms

  25. Body weight

    Time frame: 3 months

    kilograms

  26. Body weight

    Time frame: 6 months

    kilograms

  27. Body weight

    Time frame: 12 months

    kilograms

  28. Body weight

    Time frame: 18 months

    kilograms

  29. Body weight

    Time frame: 24 months

    kilograms

  30. Numbers of falls

    Time frame: Inclusion

  31. Numbers of falls

    Time frame: 3 months

  32. Numbers of falls

    Time frame: 6 months

  33. Numbers of falls

    Time frame: 12 months

  34. Numbers of falls

    Time frame: 18 months

  35. Numbers of falls

    Time frame: 24 months

  36. Physical performance score

    Time frame: Inclusion

    Short Physical Performance Battery (SPPB) test score

  37. Physical performance score

    Time frame: 2 years

    SPPB test score

  38. Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion

    Time frame: 2 years

  39. Evolution of IADL score according to the results of the ICOPE test at inclusion

    Time frame: 2 years

  40. Cognitive assessment

    Time frame: Inclusion

    Mini-Mental State Examination (MMSE) score

  41. Cognitive assessment

    Time frame: 2 years

    MMSE score

  42. Cognitive assessment

    Time frame: Inclusion

    Batterie Rapide d'Efficience Frontale (BREF) score

  43. Cognitive assessment

    Time frame: 2 years

    BREF score

  44. Cognitive assessment

    Time frame: Inclusion

    Mini Geriatric Depression Scale (GDS) score

  45. Cognitive assessment

    Time frame: 2 years

    Mini GDS score

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Baptiste Gourraud, MD

CONTACT

[email protected]

0240165143

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: EDearly AF

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Mar 20, 2024
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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