Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

Condition(s) targeted: Atrial Fibrillation; Arrhythmia; Stroke Prevention; Mortality

Intervention: Pharmacologic Therapy Rate and/or Rhythm Control (Drug); NAVI-STAR Thermo-cool (Left Atrial Catheter Ablation) (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Douglas L. Packer, M.D., Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Kristi H Monahan, RN, BA, Phone: 507-255-7456, Email: CABANA@mayo.edu

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.

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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

A composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest.

Medical costs and resource utilization and cost effectiveness

Composite adverse events

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.

Quality of Life

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.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Kristi H Monahan, RN, BA, Phone: 507-255-7456, Email: CABANA@mayo.edu

Mayo Clinic, Rochester, Minnesota 55902, United States; Recruiting
Kristi H. Monahan, RN, BA, Phone: 507-255-7456, Email: CABANA@mayo.edu
Douglas L. Packer, M.D., Principal Investigator
David Bradley, M.D., Sub-Investigator

Related 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.

Starting date: September 2006
Ending date: January 2008
Last updated: December 20, 2007