Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial - Full Text View

Sponsor:	Mayo Clinic
Collaborators:	Duke University St. Jude Medical
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00578617

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.

Condition	Intervention	Phase
Atrial Fibrillation Arrhythmia Stroke Prevention Mortality	Drug: Pharmacologic Therapy Rate and/or Rhythm Control Device: NAVI-STAR Thermo-cool (Left Atrial Catheter Ablation)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

A composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest. [ Time Frame: Trial length ] [ Designated as safety issue: Yes ]
Medical costs and resource utilization and cost effectiveness [ Time Frame: Trial length ] [ Designated as safety issue: No ]
Composite adverse events [ Time Frame: Trial length ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: 3 months and annual ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pharmacologic Therapy Rate and/or Rhythm Control	Drug: Pharmacologic Therapy Rate and/or Rhythm Control 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
2: Active Comparator Left Atrial Catheter Ablation	Device: NAVI-STAR Thermo-cool (Left Atrial Catheter Ablation) 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.

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578617

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902

Sponsors and Collaborators

Mayo Clinic

Duke University

St. Jude Medical

Investigators

Principal Investigator:

Douglas L. Packer, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Mayo Clinic ( Douglas L. Packer, MD )
Study ID Numbers:	06-003867, RO1-HL089907
Study First Received:	December 14, 2007
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00578617 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Atrial fibrillation
Left Atrial Ablation
Pulmonary Vein Isolation
Catheter Ablation
Antiarrhythmic Drug Therapy

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents

Anti-Arrhythmia Agents
Atrial Fibrillation
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010