Curing Atrial Fibrillation in Heart Failure
Information source: NHS Greater Glasgow and Clyde
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Heart Failure; Atrial Fibrillation
Intervention: radiofrequency ablation (Procedure); ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril (Drug); Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol (Drug); Aldosterone Antagonists - spironolactone (Drug)
Phase: N/A
Status: Completed
Sponsored by: NHS Greater Glasgow and Clyde Official(s) and/or principal investigator(s): Derek T Connelly, MBChB, Principal Investigator, Affiliation: Glasgow Royal Infirmary
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.
Clinical Details
Official title: Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months
Secondary outcome: Plasma B-type Natriuretic Peptide (BNP)Plasma B-type Natriuretic Peptide (BNP) at Baseline Plasma B-type Natriuretic Peptide (BNP) at 6 Months
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Glasgow Royal Infirmary, Glasgow, Scotland G31 2ER, United Kingdom
Additional Information
Starting date: January 2007
Last updated: May 29, 2012
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