Clinical trial NCT00292162: Curing Atrial Fibrillation in Heart Failure
Official title: Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Atrial Fibrillation
Keywords: Chronic Heart Failure
Atrial Fibrillation
Radiofrequency Ablation
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2006-02-15
Enrollment: 41
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart failure is a condition that occurs when the heart muscle weakens and no longer contracts normally. Half of these patients have an irregularity of heart rhythm called atrial fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and die earlier than those with heart failure alone. AF is difficult to treat with conventional methods in patients with heart failure. Radiofrequency ablation is a new technique used to cure AF. The investigators aim to establish if radiofrequency ablation for atrial fibrillation in patients with advanced heart failure can result in marked improvement in the function of the heart.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Persistent atrial fibrillation (AF)
* New York Heart Association (NYHA) II, III and IV chronic heart failure (CHF) despite optimal medical therapy for at least 3 months
* left ventricular ejection fraction (LVEF) \<35% - as measured by radionuclide ventriculography (RNVG)
* Patients with CHF secondary to ischaemic and non-ischaemic aetiology

Exclusion Criteria:

* QRS duration \>150ms (or QRS 120-150 with evidence of mechanical cardiac dysynchrony)
* Magnetic resonance imaging (MRI) - incompatible metallic (ferrous) prosthesis
* Primary valvular disease as a cause of CHF
* Reversible causes of CHF
* Acute myocarditis
* Patients aged 18 or less
* Patients having undergone revascularisation procedures within 6 months
* Paroxysmal AF
* Pregnancy
* Expected cardiac transplantation within 6 months

Primary outcomes:
measure: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%
timeFrame: baseline and 6 months
measure: Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
timeFrame: Baseline
measure: Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Plasma B-type Natriuretic Peptide (BNP)
timeFrame: baseline and 6 months
measure: Plasma B-type Natriuretic Peptide (BNP) at Baseline
timeFrame: Baseline
measure: Plasma B-type Natriuretic Peptide (BNP) at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Scotland
Study officials:
affiliation: Glasgow Royal Infirmary
name: Derek T Connelly, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacDonald MR, Connelly DT, Hawkins NM, Steedman T, Payne J, Shaw M, Denvir M, Bhagra S, Small S, Martin W, McMurray JJ, Petrie MC. Radiofrequency ablation for persistent atrial fibrillation in patients with advanced heart failure and severe left ventricular systolic dysfunction: a randomised controlled trial. Heart. 2011 May;97(9):740-7. doi: 10.1136/hrt.2010.207340. Epub 2010 Nov 4.