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OpenTrials
Completed

NCT Number: NCT00886080

The Effect of Arrhythmia Surgery on Quality of Life in Patients With Atrial Fibrillation Undergoing Cardiac Surgery

Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is frequently associated with valvular and coronary disease. In the AF patients undergoing valvular or coronary surgery the arrhythmia almost always relapses. For symptom control anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side effects of the drugs happen frequently. For more effective symptom control "add-on" arrhythmia surgery is being advocated. However, at present the investigators do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life.

The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and reduces perioperative and long-term morbidity associated with AF.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Cardiothoracic Surgery, University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

About this study

Multicentre prospective parallel randomised controlled trial. In total 150 patients with documented atrial fibrillation (chronic and paroxysmal), were randomly assigned by a central computer system to undergo cardiac surgery with add-on surgery or without. This assignment was blinded to patients and all medical personnel except for the surgical team during total follow up. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6 and 12 months following operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergo valvular surgery and/ or coronary surgery,
  • All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
  • Patients have given written informed consent.

Exclusion criteria

  • Patients who do not speak Dutch or can not read Dutch.
  • Patients with a Sick Sinus Syndrome.
  • Patients with contraindications for oral anticoagulant agents.
  • Incompetent to act for oneself

Treatment and study plan

Pulmonary vein isolation using microwave energy

Procedure

The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. The off-pump beating heart ablation procedure is performed according to a specific box lesion surrounding the pulmonary veins, using microwave energy. Afterwards cardiac surgery is performed as usual in both treatment arms.

Other names: PV-isolation

Primary outcomes

  1. Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points.

    Time frame: Baseline, 3, 6, and 12 months after operation

Secondary outcomes

  1. In-hospital and out-of-hospital morbidity and mortality during one year follow-up

    Time frame: Baseline, 1, 6 and 12 months after operation

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Profileringsfonds Maastricht

Registry information

Official study title

A Prospective Randomised Multicentre Comparison on Health Related Quality of Life: the Value of Add-on Arrhythmia Surgery in Patients With Atrial Fibrillation Undergoing Valvular and/or Coronary Bypass Surgery

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Apr 22, 2009
Registry last updated
Apr 22, 2009

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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