Atrial FibrillationCABANANCT00578617
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
A study testing Ablation Therapy in people with Atrial Fibrillation and Arrhythmia, run by Mayo Clinic at 10 sites in United States.
Trial summary
The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia
- What is being tested?
- Ablation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2006to Jun 2010
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have documented AF, which warrants active drug or ablative treatment
- Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs
- Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography
Who cannot join
- Previously failed 2 or more membrane active anti-arrhythmic drugs
- Efficacy failure of a full dose Amiodarone trial of >12 weeks duration
- Any amiodarone therapy in the past three months
- Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
- Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age
- Recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months
Show all 20Show fewer
- Hypertrophic obstructive cardiomyopathy
- Class IV angina or congestive heart failure
- Planned heart transplantation
- Other mandated anti-arrhythmic drug therapy
- Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class I or III drugs
- Prior left atrial catheter ablation with the intention to treat AF
- Patients with other arrhythmias requiring ablative therapy
- Prior surgical interventions for AF such as the MAZE procedure
- Prior atrioventricular nodal ablation
- Medical conditions limiting expected survival to <1 year
- Contraindication to warfarin anti-coagulation
- Women of childbearing potential
- Participation in any other clinical mortality trial
- Unable to give informed consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Universtity of Alabama Hospital
Birminham, Alabama, 35233
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Ohio State University Medical Center
Columbus, Ohio, 43210
Mercy Medical Center
Des Moines, Iowa, 50314
Good Samaritan Hospital
Los Angeles, California, 90017
Loyola University
Maywood, Illinois, 60626
Intermountain Medical Center
Murray, Utah, 84157
University of Pennsylvania Health
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial
The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
Read the detailed description
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.
- Conditions
- Atrial Fibrillation, Arrhythmia
- Being tested
- Rate Control, Ablation Therapy, Rhythm Control
- Keywords
- Atrial fibrillation, Left Atrial Ablation, Pulmonary Vein Isolation, Catheter Ablation, Antiarrhythmic Drug Therapy
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate ControlDrug
Also called Toprol
Metoprolol 50-100mg
Ablation TherapyDevice
Also called St. Jude: Livewire
Rate ControlDrug
Also called Tenormin
Atenolol 50-100mg,
Rate controlDrug
Also called Inderal
Propranolol 40-80mg
Rate controlDrug
Also called Sectral
Acebutolol 200mg
Rate controlDrug
Also called Coreg
Carvedilol 6.25mg
Rate ControlDrug
Also called Cardizem
Diltiazem 180-240mg
Rate ControlDrug
Also called Calan
Verapamil 180-240mg
Rate ControlDrug
Also called Lanoxin
Digoxin 0.125mg
Rhythm ControlDrug
Also called Rhythmol
Propafenone 450mg
Rhythm controlDrug
Also called Tambacor
Flecainide 200mg
Rhythm controlDrug
Also called Betapace
Sotalol 240mg
Rhythm controlDrug
Also called Tykosin
Dofetilide 500mcg
Rhythm controlDrug
Also called Cordarone
Amiodarone 200mg
Rhythm controlDrug
Also called Quini-glute/dex
Quinidine 600-900mg
| Study group | Role | What they receive |
|---|---|---|
| Pharmacologic Therapy | Active comparator | Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug. Receives: Drug: Rate Control; Drug: Rhythm Control |
| Ablation Therapy | Active comparator | Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled. Receives: Device: Ablation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Documentation of atrial fibrillation using a cardiac event recorder
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionJun 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Abbott Medical Devices
- Investigators
- Douglas L. Packer, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578617
- Sponsor's protocol ID
- 06-003867
- Acronym
- CABANA
- Status last verified
- Dec 2012
- First submitted
- 14 Dec 2007
- Last updated
- 4 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cleland JG, Coletta AP, Buga L, Ahmed D, Clark AL. Clinical trials update from the American College of Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA, RACE II, EVEREST II, ACCORD, and NAVIGATOR. Eur J Heart Fail. 2010 Jun;12(6):623-9. doi: 10.1093/eurjhf/hfq083.
PubMed 20498271
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial
- ClinicalTrials.gov ID
- NCT00578617
- Acronym / sponsor ID
- CABANA / 06-003867
- Conditions
- Atrial Fibrillation, Arrhythmia
- Keywords
- Atrial fibrillation, Left Atrial Ablation, Pulmonary Vein Isolation, Catheter Ablation, Antiarrhythmic Drug Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Abbott Medical Devices
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 4 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
Detailed description
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacologic Therapy | Active comparator | Drug: Rate Control, Drug: Rhythm ControlPharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug. |
| Ablation Therapy | Active comparator | Device: Ablation TherapyLeft Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have documented AF, which warrants active drug or ablative treatment
- Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs
- Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography
Key exclusion criteria (20 listed)
- Previously failed 2 or more membrane active anti-arrhythmic drugs
- Efficacy failure of a full dose Amiodarone trial of >12 weeks duration
- Any amiodarone therapy in the past three months
- Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
- Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age
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 |
|---|---|---|
| Rate ControlAlso: ToprolMetoprolol 50-100mg | Drug | Pharmacologic Therapy |
| Ablation TherapyAlso: St. Jude: Livewire | Device | Ablation Therapy |
| Rate ControlAlso: TenorminAtenolol 50-100mg, | Drug | Pharmacologic Therapy |
| Rate controlAlso: InderalPropranolol 40-80mg | Drug | Pharmacologic Therapy |
| Rate controlAlso: SectralAcebutolol 200mg | Drug | Pharmacologic Therapy |
| Rate controlAlso: CoregCarvedilol 6.25mg | Drug | Pharmacologic Therapy |
| Rate ControlAlso: CardizemDiltiazem 180-240mg | Drug | Pharmacologic Therapy |
| Rate ControlAlso: CalanVerapamil 180-240mg | Drug | Pharmacologic Therapy |
| Rate ControlAlso: LanoxinDigoxin 0.125mg | Drug | Pharmacologic Therapy |
| Rhythm ControlAlso: RhythmolPropafenone 450mg | Drug | Pharmacologic Therapy |
| Rhythm controlAlso: TambacorFlecainide 200mg | Drug | Pharmacologic Therapy |
| Rhythm controlAlso: BetapaceSotalol 240mg | Drug | Pharmacologic Therapy |
| Rhythm controlAlso: TykosinDofetilide 500mcg | Drug | Pharmacologic Therapy |
| Rhythm controlAlso: CordaroneAmiodarone 200mg | Drug | Pharmacologic Therapy |
| Rhythm controlAlso: Quini-glute/dexQuinidine 600-900mg | Drug | Pharmacologic Therapy |
Primary outcome
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Time frame: 12 months after intervention
Documentation of atrial fibrillation using a cardiac event recorder
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20498271Cleland JG, Coletta AP, Buga L, Ahmed D, Clark AL. Clinical trials update from the American College of Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA, RACE II, EVEREST II, ACCORD, and NAVIGATOR. Eur J Heart Fail. 2010 Jun;12(6):623-9. doi: 10.1093/eurjhf/hfq083.
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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.
Douglas L. Packer, M.D. principal investigator
Mayo Clinic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation Therapy in people with Atrial Fibrillation and Arrhythmia, run by Mayo Clinic at 10 sites in United States.
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 20 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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2013). 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?
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up (time frame: 12 months after intervention). 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 NCT00578617, 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 4 Jan 2013.