Curing Atrial Fibrillation in Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by NHS Greater Glasgow and Clyde. Recruitment status was Recruiting

First Received on February 14, 2006. Last Updated on September 17, 2009 History of Changes

Sponsor:	NHS Greater Glasgow and Clyde
Information provided by:	NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:	NCT00292162

Purpose

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.

Condition	Intervention
Chronic Heart Failure Atrial Fibrillation	Procedure: Pulmonary Vein Isolation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:

Left Ventricular Ejection Fraction by MRI

Secondary Outcome Measures:

Right ventricular ejection fraction
Maintenance of sinus rhythm
Left and right atrial and ventricular dimensions, areas and volumes
Left ventricular diastolic function
NYHA class
Plasma BNP
Functional status: 6 minute walk
Quality of life: Minnesota Living with Heart Failure, SF-36 and Kansas City Cardiomyopathy questionnaires

Estimated Enrollment:	40
Study Start Date:	January 2007
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent
Persistent AF
NYHA II, III and IV CHF despite optimal medical therapy for at least 3 months
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292162

Contacts

Contact: Michael R MacDonald, MBChB

0141 211 4000 ext 24689

michaelrossmacdonald@yahoo.com

Locations

United Kingdom
Glasgow Royal Infirmary	Recruiting
Glasgow, Scotland, United Kingdom, G31 2ER

Sponsors and Collaborators

NHS Greater Glasgow and Clyde

Investigators

Principal Investigator:

Derek T Connelly, MBChB

Glasgow Royal Infirmary

More Information

No publications provided by NHS Greater Glasgow and Clyde

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Nov 4.

ClinicalTrials.gov Identifier:	NCT00292162 History of Changes
Other Study ID Numbers:	05/S0704/47
Study First Received:	February 14, 2006
Last Updated:	September 17, 2009
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:

Chronic Heart Failure
Atrial Fibrillation
Radiofrequency Ablation

Additional relevant MeSH terms:

Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2012