Surgical Pulmonary Vein Isolation Efficiency Study

Coronary Artery Disease Clinical Trial

— FIN-PVI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01791218
• Other study ID #: KUH5101071
• Status: Terminated
• Phase: N/A
• Start date: November 2012
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• CABG, AVR or CABG+AVR and PVI

• CABG, AVR or CABG+AVR

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Eastern Finland

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation burden	Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring	Within one year after operative treatment
Primary	Freedom of symptomatic and asymptomatic atrial fibrillation after surgery	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	Within one year after operative treatment
Secondary	Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation		Within one year after operative treatment
Secondary	Adverse events after surgery in both arms		Within one year after operative treatment
Secondary	Anti-arrhythmic treatment after surgery		Within one year after treatment
Secondary	Hospitalization due to atrial fibrillation after surgery		Within one year after operative treatment
Secondary	Cardioversion for the treatment of atrial fibrillation after surgery		Within one year after operative treatment
Secondary	Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding		Within one year after operative treatment