Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure

NCT00878384 | Completed DMC

• 1 other identifier: 2008CI008B
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

It is still uncertain what the best treatment is for patients who have both atrial fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal treatment for patients with these two significant medical conditions. This will be performed by comparing two alternative strategies for AF management: catheter ablation (to restore normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal rhythm). After random assignment, the effect of each strategy will be assessed by looking for changes in exercise capacity, symptoms, heart pump function, and quality of life during 12 months of follow-up.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Atrial Fibrillation; Heart Failure; Heart Rate Control; Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption at cardiopulmonary exercise test

  12 months

Secondary Outcomes (5)

• Left ventricular ejection fraction

  12 months

• Quality of Life score

  3, 6 and 12 months

• 6 minute walk distance

  3, 6 and 12 months

• Level of plasma neurohormones (including BNP)

  3, 6 and 12 months

• Freedom from AF

  3, 6 and 12 months

Study Arms (2)

Rate control

ACTIVE COMPARATOR

Strategy of 'rate-control': acceptance of atrial fibrillation, and dose-adjusted drug therapy as needed to control ventricular rate.

Drug: Medication to control ventricular rate in AF

Catheter Ablation

ACTIVE COMPARATOR

Strategy of 'rhythm control' by catheter ablation: patients will undergo catheter ablation with the intention of restoring sinus rhythm.

Procedure: Catheter Ablation for Persistent Atrial Fibrillation

Interventions

Medication to control ventricular rate in AF DRUG

Standard pharmacologic rate control. Current therapy will be adjusted to achieve rate-control targets of \<80bpm and \<110bpm on exercise (6 minute walk). Where necessary, additional medication will be given as per standard practice (digoxin or beta-blocker). Typical does: Digoxin 62.5-250mcg o.d. ; Bisoprolol 1.25-20mg o.d.; Carvedilol 3.125-50mg b.d. ; Nebivolol 1.25-10mg o.d.

Rate control

Catheter Ablation for Persistent Atrial Fibrillation PROCEDURE

Radiofrequency catheter ablation, which may include pulmonary vein isolation, atrial substrate modification, and/or linear ablation.

Also known as: Radiofrequency catheter ablation, AF ablation, LA maze

Catheter Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, \< 80years
• NYHA II-IV symptoms
• Impairment of left ventricular systolic function (left ventricular ejection fraction estimated as ≤ 35% by radionuclide ventriculography)
• Documented AF lasting for at least 7 days (persistent or permanent AF)

You may not qualify if:

• CRT or ICD device implanted in the previous 6 months
• AV nodal ablation within previous 3 months
• Prior AV nodal ablation or complete heart block with a single chamber pacemaker
• Contraindication to anticoagulation
• Persistent thrombus in the left atrium despite anticoagulation
• Active malignancy
• Cerebrovascular accident within the previous 6 months
• Reversible causes of AF including thyroid disorders, alcohol, recent surgery
• Reversible causes of heart failure including acute myocarditis or alcohol
• Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months
• Prior AF ablation procedure
• Previous heart transplant, or on urgent heart transplant waiting list
• Severe neuro-muscular disease
• Creatinine clearance \<30 ml/min
• Serum bilirubin \>50 micromol/L

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (10)

• Hsu LF, Jais P, Sanders P, Garrigue S, Hocini M, Sacher F, Takahashi Y, Rotter M, Pasquie JL, Scavee C, Bordachar P, Clementy J, Haissaguerre M. Catheter ablation for atrial fibrillation in congestive heart failure. N Engl J Med. 2004 Dec 2;351(23):2373-83. doi: 10.1056/NEJMoa041018.

  PMID: 15575053 BACKGROUND

• Dries DL, Exner DV, Gersh BJ, Domanski MJ, Waclawiw MA, Stevenson LW. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Sep;32(3):695-703. doi: 10.1016/s0735-1097(98)00297-6.

  PMID: 9741514 BACKGROUND

• Middlekauff HR, Stevenson WG, Stevenson LW. Prognostic significance of atrial fibrillation in advanced heart failure. A study of 390 patients. Circulation. 1991 Jul;84(1):40-8. doi: 10.1161/01.cir.84.1.40.

  PMID: 2060110 BACKGROUND

• Swedberg K, Olsson LG, Charlesworth A, Cleland J, Hanrath P, Komajda M, Metra M, Torp-Pedersen C, Poole-Wilson P. Prognostic relevance of atrial fibrillation in patients with chronic heart failure on long-term treatment with beta-blockers: results from COMET. Eur Heart J. 2005 Jul;26(13):1303-8. doi: 10.1093/eurheartj/ehi166. Epub 2005 Mar 14.

  PMID: 15767288 BACKGROUND

• Roy D, Talajic M, Nattel S, Wyse DG, Dorian P, Lee KL, Bourassa MG, Arnold JM, Buxton AE, Camm AJ, Connolly SJ, Dubuc M, Ducharme A, Guerra PG, Hohnloser SH, Lambert J, Le Heuzey JY, O'Hara G, Pedersen OD, Rouleau JL, Singh BN, Stevenson LW, Stevenson WG, Thibault B, Waldo AL; Atrial Fibrillation and Congestive Heart Failure Investigators. Rhythm control versus rate control for atrial fibrillation and heart failure. N Engl J Med. 2008 Jun 19;358(25):2667-77. doi: 10.1056/NEJMoa0708789.

  PMID: 18565859 BACKGROUND

• Pedersen OD, Brendorp B, Elming H, Pehrson S, Kober L, Torp-Pedersen C. Does conversion and prevention of atrial fibrillation enhance survival in patients with left ventricular dysfunction? Evidence from the Danish Investigations of Arrhythmia and Mortality ON Dofetilide/(DIAMOND) study. Card Electrophysiol Rev. 2003 Sep;7(3):220-4. doi: 10.1023/B:CEPR.0000012386.82055.81.

  PMID: 14739717 BACKGROUND

• Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.

  PMID: 15007003 BACKGROUND

• Hagens VE, Crijns HJ, Van Veldhuisen DJ, Van Den Berg MP, Rienstra M, Ranchor AV, Bosker HA, Kamp O, Tijssen JG, Veeger NJ, Van Gelder IC; RAte Control versus Electrical cardioversion for persistent atrial fibrillation study group. Rate control versus rhythm control for patients with persistent atrial fibrillation with mild to moderate heart failure: results from the RAte Control versus Electrical cardioversion (RACE) study. Am Heart J. 2005 Jun;149(6):1106-11. doi: 10.1016/j.ahj.2004.11.030.

  PMID: 15976795 BACKGROUND

• Jones DG, Haldar SK, Jarman JW, Johar S, Hussain W, Markides V, Wong T. Impact of stepwise ablation on the biatrial substrate in patients with persistent atrial fibrillation and heart failure. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):761-8. doi: 10.1161/CIRCEP.113.000390. Epub 2013 Jul 23.

  PMID: 23881779 DERIVED

• Jones DG, Haldar SK, Hussain W, Sharma R, Francis DP, Rahman-Haley SL, McDonagh TA, Underwood SR, Markides V, Wong T. A randomized trial to assess catheter ablation versus rate control in the management of persistent atrial fibrillation in heart failure. J Am Coll Cardiol. 2013 May 7;61(18):1894-903. doi: 10.1016/j.jacc.2013.01.069. Epub 2013 Mar 7.

  PMID: 23500267 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Tom Wong, MD FESC

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

GB (1)