Paroxysmal Atrial FibrillationPhase 4NCT00540787
A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
A Phase 4 study testing Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs and ThermoCool Radiofrequency Catheter in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs and ThermoCool Radiofrequency Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Aug 2003to 1 Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States3 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mid-Ohio Cardiology
Columbus, Ohio, 43214
France2 sites
Hopital Lariboisiere
Paris, 75010
Hôpital Haut Lèvêque
Pessac, Paris
About this study
Official title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation
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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs, ThermoCool Radiofrequency Catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation, antiarrhythmic drugsDevice
Patients receive either treatment.
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.
ThermoCool Radiofrequency CatheterDevice
Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.
| Study group | Role | What they receive |
|---|---|---|
| Drug Treatment | Active comparator | Not described Receives: Device: Radiofrequency ablation, antiarrhythmic drugs; Drug: 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. Receives: Device: Radiofrequency ablation, antiarrhythmic drugs; Device: ThermoCool Radiofrequency Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (1)
Efficacy of ablation and drug treatment
Evaluation of:
- the functional state of the 2 groups of patients in terms of quality of life
- the efficacy of the subgroup receiving amiodarone as compared to curative ablation
- the incidence of secondary effects of both approaches
- the rate of withdrawal from oral anticoagulation at 1 year after randomization
- the effect of ablation for maintenance of sinus rhythm with previously ineffective drugs in case of failure of ablation strategy (after cross-over to medical treatment)
- the assessment of Atrial fibrillation burden in both groups (using patient diaries and Holter Monitors)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study start1 Aug 2003
- Primary completion1 Jun 2006
- Study completion1 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Jais, MD, Principal investigator, Hôpital Haut Lèvêque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540787
- Sponsor's protocol ID
- A4
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2007
- Last updated
- 28 Feb 2025
- Results posted
- No
Publications
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.
PubMed 19029470
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00540787
- Acronym / sponsor ID
- A4
- Conditions
- Paroxysmal Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2003 (actual)
- Primary completion
- 1 Jun 2006 (actual)
- Study completion
- 1 Jun 2006 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Treatment | Active comparator | Device: Radiofrequency ablation, antiarrhythmic drugs, Drug: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs |
| ThermoCool Radiofrequency Catheter | Active comparator | Device: Radiofrequency ablation, antiarrhythmic drugs, Device: ThermoCool Radiofrequency CatheterRadiofrequency catheter used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation, antiarrhythmic drugsPatients receive either treatment. | Device | Drug Treatment, ThermoCool Radiofrequency Catheter |
| Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugsAmiodarone 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 | Drug Treatment |
| ThermoCool Radiofrequency CatheterPatient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs. | Device | ThermoCool Radiofrequency Catheter |
Primary outcome
Recurrence of Atrial Fibrillation
Time frame: One year
To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year.
1 secondary outcome
Efficacy of ablation and drug treatment
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 19029470Jais 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Jais, MD principal investigator
Hôpital Haut Lèvêque
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs and ThermoCool Radiofrequency Catheter in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Atrial Fibrillation (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.