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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

Page last updated: August 23, 2015

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