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

Condition(s) targeted: Atrial Fibrillation; Heart Failure

Intervention: Medication to control ventricular rate in AF (Drug); Catheter Ablation for Persistent Atrial Fibrillation (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Royal Brompton & Harefield NHS Foundation Trust

Official(s) and/or principal investigator(s):
Tom Wong, MD FESC, Principal Investigator, Affiliation: Royal Brompton & Harefield NHS Foundation Trust

Overall contact:
David G Jones, BSc, MBBS, Phone: 442073518742, Email: d.jones@rbht.nhs.uk

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.

Official title: A Randomised Trial to Assess Catheter Ablation Versus Rate-Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure

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

Primary outcome: Peak oxygen consumption at cardiopulmonary exercise test

Secondary outcome:

Left ventricular ejection fraction

Quality of Life score

6 minute walk distance

Level of plasma neurohormones (including BNP)

Freedom from AF

Detailed description: Currently available evidence suggests that occurrence of AF in patients with heart failure (HF) leads to a decline in exercise tolerance, worsened quality of life, increased hospitalisation, and in many studies an increase in mortality. These may be explained by the haemodynamic effects of AF i. e. reduction in functional cardiac output due to inappropriate heart rates, irregularity, and loss of atrial contraction, plus the risk of thromboembolism.

Evidence from large clinical studies has shown that patients with heart failure fare better if sinus rhythm can be restored, but on the contrary a 'rhythm control' strategy (as intention to treat) of cardioversion or antiarrhythmic drugs to achieve sinus rhythm has not been shown to be superior to the strategy of rate control. These apparently contradictory findings might be explained by the poor efficacy and side effects associated with current rhythm control strategies, or could reflect that AF is merely a passive marker of underlying disease severity. However, many studies would point to the former, and it might be hypothesised that the theoretical benefits of sinus rhythm could be seen for real in clinical practice if a superior rhythm-control strategy was used.

Catheter ablation, a relatively new treatment for atrial fibrillation, has been shown to be feasible in a non-randomised heart failure patient cohort, with markers suggesting improvement of cardiac function.

This prospective clinical trial will enrol HF patients on optimal therapy, with documented persistent AF, and compare the strategies of catheter-ablation and medical rate control in a 1: 1 randomised fashion.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- 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)

Exclusion criteria:

- 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

- Active participation in another research study

- Unable to understand and comply with protocol or give written informed consent

- Body mass index >35 (kg/m2)

David G Jones, BSc, MBBS, Phone: 442073518742, Email: d.jones@rbht.nhs.uk

Royal Brompton & Harefield NHS Trust, London SW3 6NP, United Kingdom; Recruiting
David G Jones, BSc MBBS, Sub-Investigator
Tom Wong, MD FESC, Principal Investigator

Related publications:

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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. Epub 2004 Mar 08.

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.

Starting date: April 2009
Ending date: October 2011
Last updated: April 7, 2009