Surgical Pulmonary Vein Isolation Efficiency Study (FIN-PVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Kuopio University Hospital
Sponsor:
Information provided by (Responsible Party):
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01791218
First received: February 12, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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. 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 Intervention
Paroxysmal Atrial Fibrillation
Coronary Artery Disease
Procedure: CABG+pulmonary vein isolation (PVI)
Procedure: CABG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting: a Prospective Study

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Atrial fibrillation burden [ Time Frame: Within one year after operative treatment ] [ Designated as safety issue: No ]
    Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring

  • Freedom of symptomatic and asymptomatic atrial fibrillation after surgery [ Time Frame: Within one year after operative treatment ] [ Designated as safety issue: No ]

    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:
  • Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation [ Time Frame: Within one year after operative treatment ] [ Designated as safety issue: No ]
  • Adverse events after surgery in both arms [ Time Frame: Within one year after operative treatment ] [ Designated as safety issue: No ]
  • Anti-arrhythmic treatment after surgery [ Time Frame: Within one year after treatment ] [ Designated as safety issue: No ]
  • Hospitalization due to atrial fibrillation after surgery [ Time Frame: Within one year after operative treatment ] [ Designated as safety issue: No ]
  • Cardioversion for the treatment of atrial fibrillation after surgery [ Time Frame: Within one year after operative treatment ] [ Designated as safety issue: No ]
  • Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding [ Time Frame: Within one year after operative treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CABG+Pulmonary vein isolation
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG
Procedure: CABG+pulmonary vein isolation (PVI)
Active Comparator: CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. No operative procedures for the treatment of atrial fibrillation
Procedure: CABG

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791218

Contacts
Contact: Teemu Riekkinen 358044175527 teemu.riekkinen@kuh.fi

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

No publications provided

Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01791218     History of Changes
Other Study ID Numbers: KUH5101071
Study First Received: February 12, 2013
Last Updated: May 6, 2014
Health Authority: Finland:Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 22, 2014