Clinical trial NCT00886080: The Effect of Arrhythmia Surgery on Quality of Life in Patients With Atrial Fibrillation Undergoing Cardiac Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Health related Quality of Life
Add-on surgery
Ablation
Randomised controlled trial
SF-36
EuroQoL
MFI-20
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Profileringsfonds Maastricht
First posted: 2009-04-22
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points.
timeFrame: Baseline, 3, 6, and 12 months after operation
Secondary outcomes:
measure: In-hospital and out-of-hospital morbidity and mortality during one year follow-up
timeFrame: Baseline, 1, 6 and 12 months after operation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Dept. of Cardiothoracic Surgery, University Hospital Maastricht
Study officials:
affiliation: Maastricht University Medical Center
name: Jos G. Maessen, PhD
role: STUDY_CHAIR
References:
citation: Van Breugel HN, Nieman FH, Accord RE, Van Mastrigt GA, Nijs JF, Severens JL, Vrakking R, Maessen JG. A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery. J Cardiovasc Electrophysiol. 2010 May;21(5):511-20. doi: 10.1111/j.1540-8167.2009.01655.x. Epub 2009 Nov 17.