NCT00540787

Brief Summary

The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2003

Typical duration for phase_4

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

October 4, 2007

Last Update Submit

February 27, 2025

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Atrial Fibrillation

    To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year.

    One year

Secondary Outcomes (1)

  • Efficacy of ablation and drug treatment

    One year

Study Arms (2)

Drug Treatment

ACTIVE COMPARATOR
Device: Radiofrequency ablation, antiarrhythmic drugsDrug: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs

ThermoCool Radiofrequency Catheter

ACTIVE COMPARATOR

Radiofrequency catheter used.

Device: Radiofrequency ablation, antiarrhythmic drugsDevice: ThermoCool Radiofrequency Catheter

Interventions

Radiofrequency ablation, antiarrhythmic drugsDEVICE

Patients receive either treatment.

Drug TreatmentThermoCool Radiofrequency Catheter
Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugsDRUG

Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week.

Drug Treatment
ThermoCool Radiofrequency CatheterDEVICE

Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.

ThermoCool Radiofrequency Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
  • Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
  • Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor

You may not qualify if:

  • Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
  • History of any previous ablation for atrial fibrillation
  • Intracardiac thrombus
  • Atrial fibrillation due to reversible cause
  • Pregnancy
  • Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mid-Ohio Cardiology

Columbus, Ohio, 43214, United States

Location

Hôpital Haut Lèvêque

Pessac, Paris, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital Cantonal de Geneve

Geneva, 12111, Switzerland

Location

Related Publications (1)

  • Jais P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, Hocini M, Extramiana F, Sacher F, Bordachar P, Klein G, Weerasooriya R, Clementy J, Haissaguerre M. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008 Dec 9;118(24):2498-505. doi: 10.1161/CIRCULATIONAHA.108.772582. Epub 2008 Nov 24.

    PMID: 19029470DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency AblationAmiodaroneFlecainidePropafenoneQuinidinedofetilideSotalolcifenlineCalcium Channel BlockersAnti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingPropiophenonesKetonesOrganic ChemicalsCinchona AlkaloidsAlkaloidsQuinuclidinesHeterocyclic Compounds, Bridged-RingQuinolinesEthanolaminesAmino AlcoholsAlcoholsAminesMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic Uses

Study Officials

  • Pierre Jais, MD

    Hôpital Haut Lèvêque

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

August 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

February 28, 2025

Record last verified: 2025-02

Locations

US(3)CH(1)FR(2)