NCT00886080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2002

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

Enrollment Period

3.1 years

First QC Date

April 20, 2009

Last Update Submit

April 21, 2009

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationHealth related Quality of LifeAdd-on surgeryAblationRandomised controlled trialSF-36EuroQoLMFI-20

Outcome Measures

Primary Outcomes (1)

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

    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

    Baseline, 1, 6 and 12 months after operation

Study Arms (1)

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

Interventions

Pulmonary vein isolation using microwave energyPROCEDURE

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.

Also known as: PV-isolation
Add-on arrhythmia surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Cardiothoracic Surgery, University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19925605DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jos G. Maessen, PhD

    Maastricht University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

October 1, 2002

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

NL(1)