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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Pulmonary vein isolation using microwave energy
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Health related Quality of Life, Add-on surgery, Ablation, Randomised controlled trial, SF-36, EuroQoL, MFI-20

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Cardiothoracic Surgery, University Hospital Maastricht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Add-on arrhythmia surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 20, 2009
Last Updated
April 21, 2009
Sponsor
Maastricht University Medical Center
Collaborators
Profileringsfonds Maastricht
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1. Study Identification

Unique Protocol Identification Number
NCT00886080
Brief Title
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
Profileringsfonds Maastricht

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Health related Quality of Life, Add-on surgery, Ablation, Randomised controlled trial, SF-36, EuroQoL, MFI-20

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Add-on arrhythmia surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation using microwave energy
Other Intervention Name(s)
PV-isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
In-hospital and out-of-hospital morbidity and mortality during one year follow-up
Time Frame
Baseline, 1, 6 and 12 months after operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jos G. Maessen, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Cardiothoracic Surgery, University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19925605
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.
Results Reference
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The Effect of Arrhythmia Surgery on Quality of Life in Patients With Atrial Fibrillation Undergoing Cardiac Surgery

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