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Surgical Pulmonary Vein Isolation Efficiency Study (FIN-PVI)

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ClinicalTrials.gov Identifier: NCT01791218
Recruitment Status : Terminated (Not enough patients for study arms)
First Posted : February 13, 2013
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Coronary Artery Disease Procedure: CABG, AVR or CABG+AVR and PVI Procedure: CABG, AVR or CABG+AVR

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting and Aortic Valve Replacement for Aortic Stenosis: a Prospective Study
Study Start Date : November 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : September 2017


Arms and Interventions

Arm Intervention/treatment
Experimental: 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
Procedure: CABG, AVR or CABG+AVR and PVI
Active Comparator: 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
Procedure: CABG, AVR or CABG+AVR


Outcome Measures

Primary Outcome Measures :
  1. Atrial fibrillation burden [ Time Frame: Within one year after operative treatment ]
    Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring

  2. Freedom of symptomatic and asymptomatic atrial fibrillation after surgery [ Time Frame: Within one year after operative treatment ]

    Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds.

    Freedom of atrial fibrillation is defined as duration of atrial fibrillation less than 0,5% of the one week Holter monitoring



Secondary Outcome Measures :
  1. Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation [ Time Frame: Within one year after operative treatment ]
  2. Adverse events after surgery in both arms [ Time Frame: Within one year after operative treatment ]
  3. Anti-arrhythmic treatment after surgery [ Time Frame: Within one year after treatment ]
  4. Hospitalization due to atrial fibrillation after surgery [ Time Frame: Within one year after operative treatment ]
  5. Cardioversion for the treatment of atrial fibrillation after surgery [ Time Frame: Within one year after operative treatment ]
  6. Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding [ Time Frame: Within one year after operative treatment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791218


Locations
Finland
Kuopio University Hospital
Kuopio, Eastern Finland, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
More Information

Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01791218     History of Changes
Other Study ID Numbers: KUH5101071
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Kuopio University Hospital:
Pulmonary vein isolation
Paroxysmal atrial fibrillation
Quality of life

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases