Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery

NCT01360918 | Terminated

• 1 other identifier: NL35192.044.11
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial fibrillation

  The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.

  one year

Secondary Outcomes (1)

• Duration of hospitalization

  One year

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Other: Usual care

Pulmonary vein isolation

ACTIVE COMPARATOR

Device: Epicardial pulmonary vein isolation

Interventions

Epicardial pulmonary vein isolation DEVICE

After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.

Also known as: Medtronic Cardioblate BP2

Pulmonary vein isolation

Usual care OTHER

Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.

Usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age
• EHRA class ≤ 2
• Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
• Patients will have elective coronary surgery planned Able of providing informed consent

You may not qualify if:

• Patients ≥70 years of age
• Pregnancy Patients with contraindications for oral anticoagulant agents
• Patients undergoing emergency operation
• Patients undergoing concomitant valve replacement
• Severely enlarged LA (\>50 mm) on echocardiography
• Prior AF ablation or AF surgery

Sponsors & Collaborators

• Medisch Spectrum Twente: lead
• Foundation of Cardiovascular Research and Education Enschede: collaborator

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcoen Scholten, MD PhD

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B. Oude Velthuis MD.

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 26, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

NL (1)