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Completed

NCT Number: NCT00292162

Curing Atrial Fibrillation in Heart Failure

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.

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Key information

Conditions

Chronic Heart Failure Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

isolation of the pulmonary veins with radiofrequency ablation (RFA)

Other names: radiofrequency ablation (RFA), pulmonary vein isolation (PVI)

ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril

Drug

Evidence based treatment for heart failure. Dose and type will depend on patient tolerability.

Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol

Drug

Evidence based treatment for heart failure. Dose and type will depend on patient tolerance.

Aldosterone Antagonists - spironolactone

Drug

Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%

    Time frame: baseline and 6 months

    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.

  2. Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)

    Time frame: Baseline

    Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %

  3. Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months

    Time frame: 6 months

    Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months

Secondary outcomes

  1. Plasma B-type Natriuretic Peptide (BNP)

    Time frame: baseline and 6 months

    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.

  2. Plasma B-type Natriuretic Peptide (BNP) at Baseline

    Time frame: Baseline

    Plasma B-type Natriuretic Peptide (BNP) measured at basline

  3. Plasma B-type Natriuretic Peptide (BNP) at 6 Months

    Time frame: 6 months

    Plasma B-type Natriuretic Peptide (BNP)

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Registry information

Official study title

Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 15, 2006
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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