Atrial FibrillationPhase 4CACAF-2NCT00227344

CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation

A Phase 4 study testing RF ablation and Antiarrhythmic drugs in people with Atrial Fibrillation, run by Biosense Webster EMEA.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: RF ablation and Antiarrhythmic drugs
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: No sites listed yet
Study dates: Dec 2004to May 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-70 years
Written informed consent
One documented relapse of atrial fibrillation (AF) during antiarrhythmic drug therapy after an electrical cardioversion

Who cannot join

Permanent atrial fibrillation
Patients who had tried >1 antiarrhythmic drug (Class I or Class III).
AF was the sole rhythm for >6 months before the enrollment.
Previous ablation for AF.
AF is deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy.
Patients who have fibrillation episodes triggered by another uniform arrhythmia (eg, atrial flutter or atrial tachycardia).

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Patients with intra-atrial thrombus, tumor, or another abnormality that precludes catheter introduction.
Patients with Wolf-Parkinson-White syndrome.
Patients awaiting cardiac transplantation.
Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-III-IV or ejection fraction (EF) <40%.
Patients with unstable angina or acute myocardial infarction within 3 months.
Patients with cardiac revascularization or other cardiac surgery within 6 months.
Patients with heart disease in which corrective surgery is anticipated.
Patients in whom appropriate vascular access is precluded.
Pregnant women.
A separate requirement for antiarrhythmic drug treatment, which will require an antiarrhythmic drug not previously tried for AF suppression.
Prior atrial surgery.
Contraindication to treatment with warfarin or other bleeding diathesis.
Renal failure requiring dialysis.
Hepatic failure.
Participant in investigational clinical or device trial.
Unwilling or unable to give informed consent.
Inaccessible for follow-up.
Psychological problem that might limit compliance.
Active abuse of alcohol or other drugs which may be causative of AF.
An implanted device (pacemaker or cardioverter-defibrillator).
Left atrial diameter (anteroposterior) >50 mm.

About this study

Official title: Catheter Ablation for Cure of Atrial Fibrillation

The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months.

Conditions: Atrial Fibrillation
Being tested: RF ablation, Antiarrhythmic drugs
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RF ablationDevice
Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System
Antiarrhythmic drugsDrug
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study

Study groups in NCT00227344
Study group	Role	What they receive
1	Experimental	Catheter ablation Receives: Device: RF ablation
2	Active comparator	Antiarrhythmic drugs Receives: Drug: Antiarrhythmic drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.
Measured: within first 24 months after a 2-month run-in phase

Secondary outcomes (7)

Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)
Measured: within first 24 months after a 2-month run-in phase
Percentage of Procedural Success
Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following:
1. "Has a validation of the lesions been performed by taking 3 points inside each circular lesion?"
2. "If YES to #1, did you observe that none of them exceed 0.1 mV?"
3. "Did you observe any adverse event during the procedure?"
If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success.
Measured: The day of the procedure
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
Measured: day 61 through 790
Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs
Measured: at 26 months and at each patients last follow-up visit
Quality of Life
Measured: at 14, 26 and 38 months
Health-economics Parameters (Days of Hospitalization)
Measured: at 26 months and at each patients last follow-up visit
Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor
Measured: at each patients last follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004May 2009

First posted28 Sep 2005 (estimated)
Study startDec 2004
Primary completionOct 2008
Study completionMay 2009

Why it stopped: Study prematurely terminated due to randomization imbalance.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00227344
Sponsor's protocol ID: CACAF2
Acronym: CACAF-2
Status last verified: Jan 2025
First submitted: 15 Sep 2005
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Catheter Ablation for Cure of Atrial Fibrillation
ClinicalTrials.gov ID: NCT00227344
Acronym / sponsor ID: CACAF-2 / CACAF2
Conditions: Atrial Fibrillation
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study prematurely terminated due to randomization imbalance.
Enrolment: 129 participants (actual)
Lead sponsor: Biosense Webster EMEAIndustry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Oct 2008 (actual)
Study completion: May 2009 (actual)
First posted: 28 Sep 2005 (estimated)
Results: Posted 14 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: RF ablationCatheter ablation
2	Active comparator	Drug: Antiarrhythmic drugsAntiarrhythmic drugs

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18-70 years
Written informed consent
One documented relapse of atrial fibrillation (AF) during antiarrhythmic drug therapy after an electrical cardioversion

Key exclusion criteria (27 listed)

Permanent atrial fibrillation
Patients who had tried >1 antiarrhythmic drug (Class I or Class III).
AF was the sole rhythm for >6 months before the enrollment.
Previous ablation for AF.
AF is deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy.

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
RF ablationCatheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System	Device	1
Antiarrhythmic drugsBest antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study	Drug	2

Primary outcome

Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
Time frame: within first 24 months after a 2-month run-in phase
Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.

7 secondary outcomes

Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)
Time frame: within first 24 months after a 2-month run-in phase
Percentage of Procedural Success
Time frame: The day of the procedure
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
Time frame: day 61 through 790
Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs
Time frame: at 26 months and at each patients last follow-up visit
Quality of Life
Time frame: at 14, 26 and 38 months
Health-economics Parameters (Days of Hospitalization)
Time frame: at 26 months and at each patients last follow-up visit
Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor
Time frame: at each patients last follow-up visit

Results and safety

Results posted to the registry on 14 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Catheter Ablation	87	75
Antiarrhythmic Drug Treatment	42	37

Primary outcome: Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).

Time frame: within first 24 months after a 2-month run-in phase. Number. Unit: percentage of participants

Measure	Catheter Ablation n = 75	Antiarrhythmic Drug Treatment n = 37
Value	36.0	45.9

Population analysed: Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Catheter Ablation	25 of 87 (28.7%)	0 of 87 (0%)	Not reported
Antiarrhythmic Drug Treatment	22 of 42 (52.4%)	3 of 42 (7.1%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early due to randomization imbalance. The relatively small number of subjects enrolled limited the amount of data available for analysis. Because the study did not reach its targeted enrollment, the study is underpowered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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.

Emanuele Bertaglia, MD principal investigator

ULSS n.13, Mirano (VE), Italy

Giuseppe Stabile, MD principal investigator

Casa di Cura San Michele, Maddaloni, Italy

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing RF ablation and Antiarrhythmic drugs in people with Atrial Fibrillation, run by Biosense Webster EMEA.

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 3 inclusion and 27 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: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 14 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months). (time frame: within first 24 months after a 2-month run-in phase). 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 NCT00227344.

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 4 Feb 2025.