Surgical Pulmonary Vein Isolation Efficiency Study

NCT ID: NCT01791218

Last Updated: 2020-09-02

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

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2020-09-30

Brief Summary

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A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.

There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.

Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CABG, AVR or CABG+AVR and PVI

Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis (AVR) or combination (CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation (PVI) in CBP prior to occlusion and CABG

Group Type EXPERIMENTAL

CABG, AVR or CABG+AVR and PVI

Intervention Type PROCEDURE

CABG, AVR or CABG+AVR

Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis(AVR) or combination(CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. No operative procedures for the treatment of atrial fibrillation

Group Type ACTIVE_COMPARATOR

CABG, AVR or CABG+AVR

Intervention Type PROCEDURE

Interventions

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CABG, AVR or CABG+AVR and PVI

Intervention Type PROCEDURE

CABG, AVR or CABG+AVR

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
* At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months
* Duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion
* written and verbal consent

Exclusion Criteria

* Prior cardiac surgery
* Active pacemaker treatment
* Active anti-arrhythmic treatment(AAD) class I and III
* Contraindication to oral anticoagulant/heparin treatment
* Ejection fraction less than 30 % (EF \< 30 %)assessed by transthoracic echocardiography
* Left atrial diameter less than 55mm assessed by transthoracic echocardiography
* Renal insufficiency requiring dialysis
* Heart valve disease requiring invasive treatment
* Heart anomaly requiring regular controls and/or invasive treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kuopio University Hospital

Kuopio, Eastern Finland, Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5101071

Identifier Type: -

Identifier Source: org_study_id

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