Expired Study
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Rochester, Minnesota 55902


Purpose:

CABANA 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 total mortality (primary endpoint) and decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding and cardiac arrest (secondary endpoint) in patients with untreated or incompletely treated AF warranting therapy.


Study summary:

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. This study will randomize patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (>65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and >2 anti-arrhythmic or >3 rate control drugs. Pts will be followed every 6 months for >2 yrs and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.


Criteria:

Inclusion Criteria: - 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 TIA, Left atrium >4.5 cm, EF <35% by echocardiogram, radionuclide evaluation or contrast ventriculography Exclusion Criteria: - 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 MI, PCI, or valve or coronary bypass surgery in the preceding 3 months - 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 with class I or III drugs - Prior LA 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 AV 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


Study is Available At:


Original ID:

06-003867


NCT ID:

NCT00578617


Secondary ID:

RO1-HL089907


Study Acronym:

CABANA


Brief Title:

Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial


Official Title:

Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Douglas L. Packer, M.D.
Principal Investigator
Mayo Clinic

Study Dates

Start Date:September 2006
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:February 2009
Primary Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 10, 2010
First Received Date:December 14, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quality of Life
Time Frame:3 months and annual
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Determine the impact of age, AF type, symptom state, and presence of underlying disease on these outcomes and establish the importance of AF elimination in this population of patients.
Time Frame:Trial length
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Composite adverse events
Time Frame:Trial length
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Medical costs and resource utilization and cost effectiveness
Time Frame:Trial length
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:A composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest.
Time Frame:Trial length
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Percutaneous left atrial catheter ablation for the purpose of eliminating AF is superior to current state-of-the-art therapy with either rate or rhythm control drugs for reducing total mortality in patients with untreated or under-treated AF.
Time Frame:Trial length
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Pharmacologic Therapy Rate and/or Rhythm Control
Description:Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200mg, Carvedilol 6.25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125mg. Rhythm control: Propafenone 450mg, Flecainide 200mg, Sotalol 240mg, Dofetilide 500mcg, Amiodarone 200mg, Quinidine 600-900mg
Arm Name:1
Intervention Type:Device
Name:NAVI-STAR Thermo-cool (Left Atrial Catheter Ablati
Description:St. Jude: Livewire, Therapy Dual / Thermocouple. Biosense Webster: NAVI-STAR/ NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-cool. CryoCath Technologies: Freezor/Freezor Max. Bard: Stinger. Boston Scientific: Blazer II RF/RPM/SteeroCath/XP, Chilli Cooled.
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Left Atrial Catheter Ablation
Study Arm Type:Active Comparator
Arm Name:1
Description:Pharmacologic Therapy Rate and/or Rhythm Control

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:Other
Agency Type:Collaborator
Agency Name:Duke University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. Epub 2005 Oct 7.
PMID:16214831
Reference Type:Reference
Citation:Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Packer D, Skanes A. Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. 2005 Mar 8;111(9):1100-5. Epub 2005 Feb 21.
PMID:15723973
Reference Type:Reference
Citation:Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97.
PMID:12875749
Reference Type:Reference
Citation:Packer DL, Asirvatham S, Munger TM. Progress in nonpharmacologic therapy of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Dec;14(12 Suppl):S296-309. Review. No abstract available.
PMID:15005218
Reference Type:Reference
Citation:Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33.
PMID:12466506
Reference Type:Reference
Citation:Tsang TS, Petty GW, Barnes ME, O'Fallon WM, Bailey KR, Wiebers DO, Sicks JD, Christianson TJ, Seward JB, Gersh BJ. The prevalence of atrial fibrillation in incident stroke cases and matched population controls in Rochester, Minnesota: changes over three decades. J Am Coll Cardiol. 2003 Jul 2;42(1):93-100.
PMID:12849666
Reference Type:Reference
Citation:Wang TJ, Larson MG, Levy D, Vasan RS, Leip EP, Wolf PA, D'Agostino RB, Murabito JM, Kannel WB, Benjamin EJ. Temporal relations of atrial fibrillation and congestive heart failure and their joint influence on mortality: the Framingham Heart Study. Circulation. 2003 Jun 17;107(23):2920-5. Epub 2003 May 27.
PMID:12771006
Reference Type:Reference
Citation:Maisel WH, Stevenson LW. Atrial fibrillation in heart failure: epidemiology, pathophysiology, and rationale for therapy. Am J Cardiol. 2003 Mar 20;91(6A):2D-8D. Review.
PMID:12670636
Reference Type:Reference
Citation:Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. Epub 2004 Aug 16.
PMID:15313941
Reference Type:Reference
Citation:Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5.
PMID:11343485

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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