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The Value of add-on Arrhythmia Surgery in Patients With Atrial Fibrillation Undergoing Cardiac Surgery

NCT ID: NCT01019759

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2006-12-31

Brief Summary

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The hypothesis being studied is that add-on arrhythmia surgery in patients with atrial fibrillation (AF) undergoing valvular or coronary surgery improves quality of life, is cost-effective, reduces perioperative and long-term morbidity associated with AF.

Detailed Description

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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 we do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life. In this respect the benefit of chronic sinus rhythm has to outweigh the risks of a prolonged operation. In addition, cardiovascular complaints unrelated to AF may persist even after successful operation, thus offsetting the benefit of chronic sinus rhythm. Add-on surgery is more costly than standard surgery but this may compare favourably with shorter hospital admission due to less frequent post-operative AF.

Valvular heart disease is frequently associated with ventricular remodelling: a decreased ventricular function and atrial dilatation. AF itself may worsen heart failure due to a tachycardiomyopathy. Elimination of AF might therefore enhance recovery from structural and functional remodelling and promote recovery of quality of life after the operation.

The PIAF, RACE and AFFIRM have shown that chronic sinus rhythm is not necessarily associated with a reduced morbidity or enhanced quality of life. PIAF however showed that exercise tolerance was better when rhythm control was achieved. Further analyses of RACE and AFFIRM are pending. One drawback of the above studies is the fact that chronic sinus rhythm is difficult to obtain. In PIAF, RACE and AFFIRM only 30 to 50% was in sinus rhythm at the end of follow-up. By contrast, arrhythmia surgery is a highly effective treatment in this respect.

Forty patients underwent a (phase 1-study) coronary bypass- or valve surgery with add-on arrhythmia surgery in the same way as in this protocol proposed. This means epicardial on beating heart and without use of the heart-lung machine. In the last follow-up 80 % of the patients not longer were in atrial fibrillation. With similar treatment procedures, but more invasive, so on the arrested heart and endo cardially, success percentages reported varying from 60 % till 80%.

This large variance in success rate is probably related to the primary course of the disease and the degree of the morphological abnormality. In spite of these meaningful results ''add-on'' arrhythmia surgery is no general accepted treatment. The intended patient population remains generally untreated. Historical data of patients from the university hospital of Maastricht show that no add on treatment has a success rate of 25% of patients in sinus rhythm.

Considering the above a randomised comparison of add-on arrhythmia surgery and standard surgery is warranted.

Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation cardiac surgery ablation pulmonary veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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No add-on AF-surgery

patient undergoing only scheduled valve and/or coronary bypass surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

PV isolation

patient undergoing add-on epicardial microwave energy pulmonary vein isolation

Group Type EXPERIMENTAL

pulmonary vein isolation

Intervention Type PROCEDURE

The off-pump beating heart ablation procedure is performed. Using a Microwave (MW) energy ablation tool (Microwave generator by Guidant), epicardial ablation line isolating the pulmonary veins are applied during open heart surgery

Interventions

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pulmonary vein isolation

The off-pump beating heart ablation procedure is performed. Using a Microwave (MW) energy ablation tool (Microwave generator by Guidant), epicardial ablation line isolating the pulmonary veins are applied during open heart surgery

Intervention Type PROCEDURE

Other Intervention Names

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Microwave generator by Guidant Flex 4 or Flex 10 ablation probes by Guidant

Eligibility Criteria

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Inclusion Criteria

1. Patients undergo valvular surgery, coronary surgery, or a combination of both.
2. All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
3. Patients have given written informed consent.

Exclusion Criteria

1. Patients who do not speak Dutch or can not read Dutch.
2. Patients with a Sick Sinus Syndrome.
3. Patients with contraindications for oral anticoagulant agents.
4. Patients unable to express their specific wishes.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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dept Cardiothoracic Surgery, Maastricht University Medical Center

Principal Investigators

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Jos G Maessen,, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

dept. Cardiothoracic Surgery, University hospital of Maastricht

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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PF 178

Identifier Type: -

Identifier Source: secondary_id

MEC 02-119.3

Identifier Type: -

Identifier Source: org_study_id