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 (EDearly AF)

April 25, 2025 updated by: Nantes University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
294

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rhythm control by Pulmonary Vein Isolation (PVI) procedure
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.
Active Comparator: Conventional care by antiarrhythmic drugs or bradycardic drugs
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke
Time Frame: 2 years
Days
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 6 months
kilograms
6 months
Number of PVI peri-procedural complications
Time Frame: 48 hours
48 hours
Number of complications
Time Frame: 2 years
2 years
Quality of life score
Time Frame: Inclusion
EQ-5D-5L score
Inclusion
Quality of life score
Time Frame: 3 months
EQ-5D-5L score
3 months
Quality of life score
Time Frame: 6 months
EQ-5D-5L score
6 months
Quality of life score
Time Frame: 12 months
EQ-5D-5L score
12 months
Quality of life score
Time Frame: 18 months
EQ-5D-5L score
18 months
Quality of life score
Time Frame: 24 months
EQ-5D-5L score
24 months
Number of documented episodes of AF
Time Frame: 2 years
2 years
Number of patients treated by cardiovascular drugs
Time Frame: 2 years
2 years
Doses of cardiovascular drugs
Time Frame: 2 years
milligrams
2 years
Autonomy score
Time Frame: Inclusion
Activities of Daily Living (ADL) score
Inclusion
Autonomy score
Time Frame: 3 months
ADL score
3 months
Autonomy score
Time Frame: 6 months
ADL score
6 months
Autonomy score
Time Frame: 12 months
ADL score
12 months
Autonomy score
Time Frame: 18 months
ADL score
18 months
Autonomy score
Time Frame: 24 months
ADL score
24 months
Autonomy score
Time Frame: Inclusion
Instrumental Activities of Daily Living (IADL) score
Inclusion
Autonomy score
Time Frame: 3 months
IADL score
3 months
Autonomy score
Time Frame: 6 months
IADL score
6 months
Autonomy score
Time Frame: 12 months
IADL score
12 months
Autonomy score
Time Frame: 18 months
IADL score
18 months
Autonomy score
Time Frame: 24 months
IADL score
24 months
Body weight
Time Frame: Inclusion
kilograms
Inclusion
Body weight
Time Frame: 3 months
kilograms
3 months
Body weight
Time Frame: 12 months
kilograms
12 months
Body weight
Time Frame: 18 months
kilograms
18 months
Body weight
Time Frame: 24 months
kilograms
24 months
Numbers of falls
Time Frame: Inclusion
Inclusion
Numbers of falls
Time Frame: 3 months
3 months
Numbers of falls
Time Frame: 6 months
6 months
Numbers of falls
Time Frame: 12 months
12 months
Numbers of falls
Time Frame: 18 months
18 months
Numbers of falls
Time Frame: 24 months
24 months
Physical performance score
Time Frame: Inclusion
Short Physical Performance Battery (SPPB) test score
Inclusion
Physical performance score
Time Frame: 2 years
SPPB test score
2 years
Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion
Time Frame: 2 years
2 years
Evolution of IADL score according to the results of the ICOPE test at inclusion
Time Frame: 2 years
2 years
Cognitive assessment
Time Frame: Inclusion
Mini-Mental State Examination (MMSE) score
Inclusion
Cognitive assessment
Time Frame: 2 years
MMSE score
2 years
Cognitive assessment
Time Frame: Inclusion
Batterie Rapide d'Efficience Frontale (BREF) score
Inclusion
Cognitive assessment
Time Frame: 2 years
BREF score
2 years
Cognitive assessment
Time Frame: Inclusion
Mini Geriatric Depression Scale (GDS) score
Inclusion
Cognitive assessment
Time Frame: 2 years
Mini GDS score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Baptiste Gourraud, MD, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC22_0450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

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