Curing Atrial Fibrillation in Heart Failure

Atrial Fibrillation Clinical Trial

Official title:

Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292162
• Other study ID #: 05/S0704/47
• Status: Completed
• Phase: N/A
• First received: February 14, 2006
• Last updated: May 29, 2012
• Start date: January 2007
• Est. completion date: July 2009

Study information

• Verified date: May 2012
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Heart Failure
• Heart Failure

Intervention

Procedure:
• radiofrequency ablation
isolation of the pulmonary veins with radiofrequency ablation (RFA)

Drug:
• ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril
Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.
• Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.
• Aldosterone Antagonists - spironolactone
Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%	left ventricular ejection fraction (LVEF) is a measure of the % of blood ejected from the ventricle in one heart beat. It is a measure of cardiac function. We measured LVEF at baseline and at 6 months, to assess whether there had been a change in the patients cardiac function over time.	baseline and 6 months	No
Primary	Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)	Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %	Baseline	No
Primary	Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months	Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months	6 months	No
Secondary	Plasma B-type Natriuretic Peptide (BNP)	venous blood taken to assess levels of the above peptide. High evels of the peptide are associated with adverse prognosis. Blood levels are taken at baseline and 6 months. The change over 6 months is assessed, thereore it is possible to have a negative number if the level falls.	baseline and 6 months	No
Secondary	Plasma B-type Natriuretic Peptide (BNP) at Baseline	Plasma B-type Natriuretic Peptide (BNP) measured at basline	Baseline	No
Secondary	Plasma B-type Natriuretic Peptide (BNP) at 6 Months	Plasma B-type Natriuretic Peptide (BNP)	6 months	No