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

February 12, 2013
May 6, 2014
November 2012
December 2015   (final data collection date for primary outcome measure)
  • 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

Same as current
Complete list of historical versions of study NCT01791218 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Surgical Pulmonary Vein Isolation Efficiency Study
Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting: a Prospective Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Paroxysmal Atrial Fibrillation
  • Coronary Artery Disease
  • Procedure: CABG+pulmonary vein isolation (PVI)
  • Procedure: CABG
  • 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
    Intervention: 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
    Intervention: Procedure: CABG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2017
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Teemu Riekkinen 358044175527 teemu.riekkinen@kuh.fi
Finland
 
NCT01791218
KUH5101071
Yes
Kuopio University Hospital
Kuopio University Hospital
Not Provided
Not Provided
Kuopio University Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP