N/A
N=41
Curing Atrial Fibrillation in Heart Failure
Chronic Heart Failure · Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00292162 ↗Enrolled (actual)
41
Serious AEs
9.8%
Results posted
Jun 2012
Primary outcome: Primary: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% — 2.8; 4.5 percentage of blood ejected in one beat
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- radiofrequency ablation (Procedure); ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril (Drug); Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol (Drug); Aldosterone Antagonists - spironolactone (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- NHS Greater Glasgow and Clyde
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% |
2.8; 4.5 | — |
| PRIMARY Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) |
43; 36 | — |
| PRIMARY Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months |
46; 41 | — |
| SECONDARY Plasma B-type Natriuretic Peptide (BNP) |
85; -196 | — |
| SECONDARY Plasma B-type Natriuretic Peptide (BNP) at Baseline |
1846; 2550 | — |
| SECONDARY Plasma B-type Natriuretic Peptide (BNP) at 6 Months |
1931; 2354 | — |
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) 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
Data sourced from ClinicalTrials.gov (NCT00292162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.