The Effect of Arrhythmia Surgery on Quality of Life in Patients With Atrial Fibrillation Undergoing Cardiac Surgery - Full Text View

Sponsors and Collaborators:	Maastricht University Medical Center Profileringsfonds Maastricht
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00886080

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Procedure: Pulmonary vein isolation using microwave energy

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

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Surgery Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In-hospital and out-of-hospital morbidity and mortality during one year follow-up [ Time Frame: Baseline, 1, 6 and 12 months after operation ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	October 2002
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Add-on arrhythmia surgery: Experimental Adjuvant anti-arrhythmic surgery consists of a beating heart epicardial "box" isolation of all pulmonary veins using microwave energy (Flex 4 or Flex 10 ablation probes and Microwave generator by Guidant/Afix, Fremont, CA, USA). The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. In addition excision or exclusion of the left atrial appendage is performed in both the treated as the control group.	Procedure: Pulmonary vein isolation using microwave energy 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.

Arms

Assigned Interventions

Add-on arrhythmia surgery: Experimental

Adjuvant anti-arrhythmic surgery consists of a beating heart epicardial "box" isolation of all pulmonary veins using microwave energy (Flex 4 or Flex 10 ablation probes and Microwave generator by Guidant/Afix, Fremont, CA, USA). The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. In addition excision or exclusion of the left atrial appendage is performed in both the treated as the control group.

Procedure: Pulmonary vein isolation using microwave energy

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.

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886080

Locations

Netherlands
Dept. of Cardiothoracic Surgery, University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ

Sponsors and Collaborators

Maastricht University Medical Center

Profileringsfonds Maastricht

Investigators

Study Chair:

Jos G. Maessen, PhD

Maastricht University Medical Center

More Information

No publications provided

Responsible Party:	University Hospital Maastricht ( H.N.A.M. van Breugel, MD )
Study ID Numbers:	PF 178, PF 178
Study First Received:	April 20, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00886080 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

Atrial fibrillation
Health related Quality of Life
Add-on surgery
Ablation

Randomised controlled trial
SF-36
EuroQoL
MFI-20

Study placed in the following topic categories:

Heart Diseases
Quality of Life
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009