Effectiveness of Pulmonary Vein Isolation in Prevention of Atrial Fibrillation Following Heart Bypass Surgery

NCT00338715 | Completed Phase 3

• 2 other identifiers: R-06-03511973
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is an irregular heart rhythm that occurs in 30% to 40% of patients following heart surgery. This irregular heart rhythm, although often self-limiting, can be cause for concern. AF is associated with a two-fold increase in patient complications and mortality after heart surgery. During AF, the heart muscle does not contract properly causing the blood flow through the heart to slow down potentially forming clots. A clot may then enter the blood stream and be carried to the brain, possibly causing a stroke. Patients in persistent AF require blood thinners to prevent strokes, and this carries its own bleeding risks especially in elderly patients. Patients in AF after heart surgery spend twice as many days in the intensive care unit and 3 to 4 more days in the hospital, hence the impact on hospital resources is quite significant. Various medications are used to prevent AF after heart surgery but they are unable to completely prevent this complication and the medications have associated side effects. In an effort to optimize the care of heart surgery patients, strategies set on eliminating the onset of AF after surgery, as opposed to trying to control AF with less than effective medications, is a necessity. We are proposing a study to determine if isolating the misfiring areas that cause AF at the time of bypass surgery in high-risk patients will decrease the occurrence of AF following heart surgery. Consenting patients will be randomized to one of two groups. Group 1 will undergo bypass surgery plus the additional procedure of pulmonary vein isolation and Group 2 will undergo bypass surgery only, without the additional procedure. Four staff cardiac surgeons at the London Health Sciences Centre will perform all surgeries. Patients will be seen postoperatively every six months and will be followed for a two-year period. The occurrence of AF will be recorded as well as other complications and lengths of hospital stay. We predict that the group with the additional pulmonary vein isolation procedure to prevent AF will have a much lower occurrence of this complication. If this is found to be beneficial, this will significantly decrease the complications and mortality associated with heart surgery. This will have a profound effect in the delivery of care to patients with coronary artery disease and other forms of heart disease.

Conditions

Atrial Fibrillation

Keywords

Effectiveness; Pulmonary Vein Isolation Procedure; Coronary Artery Bypass Surgery; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative atrial fibrillation as documented on telemetry/ECG for >=30 minutes while in hospital or AF requiring immediate intervention ie.cardioversion

  while in hospital

Secondary Outcomes (1)

• Composite endpoint of perioperative death +/- one of 10 major complications.

  while in hospital and within 30 days of discharge from hospital

Study Arms (1)

A

EXPERIMENTAL

Prophylactic Pulmonary Vein Isolation in Addition to CABG for the prevention of postoperative Atrial Fibrillation

Device: PVI with Medtronic's Cardioblate BP2 radiofrequency catheter

Interventions

PVI with Medtronic's Cardioblate BP2 radiofrequency catheter DEVICE

Ablation of the right and left pulmonary veins

Also known as: Medtronic's Cardioblate BP2 radiofrequency catheter

A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (Age\>=18) undergoing elective coronary artery bypass grafting with cardiopulmonary bypass by 4 surgeons at the London Health Sciences Centre
• Patients at high risk of developing postoperative atrial fibrillation--patients are required to meet one or more of the following criteria:
• Age \>=65
• Ejection Fraction \<50% or Left Ventricle Grade of 2-3
• Diabetes Mellitus (independent of type of management)

You may not qualify if:

• Any documented prior history of atrial fibrillation (paroxysmal/chronic)
• Contraindication to Beta Blockers
• Severe COPD with intolerance to Beta Blockers
• Concomitant non-CABG procedure
• Enrollment in another RCT
• Inability to obtain informed consent
• Patients' inability to attend follow-up visits
• Grade IV left ventricle (EF \<20%)
• Redo CABG procedure
• Off-pump coronary artery bypass surgery

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Medtronic: collaborator

Study Sites (1)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (9)

• Crystal E, Connolly SJ, Sleik K, Ginger TJ, Yusuf S. Interventions on prevention of postoperative atrial fibrillation in patients undergoing heart surgery: a meta-analysis. Circulation. 2002 Jul 2;106(1):75-80. doi: 10.1161/01.cir.0000021113.44111.3e.

  PMID: 12093773 BACKGROUND

• DiDomenico RJ, Massad MG. Pharmacologic strategies for prevention of atrial fibrillation after open heart surgery. Ann Thorac Surg. 2005 Feb;79(2):728-40. doi: 10.1016/j.athoracsur.2004.03.037.

  PMID: 15680883 BACKGROUND

• Onalan O, Lashevsky I, Crystal E. Prophylaxis and management of postoperative atrial fibrillation. Curr Cardiol Rep. 2005 Sep;7(5):382-90. doi: 10.1007/s11886-005-0093-4.

  PMID: 16105495 BACKGROUND

• Crystal E, Healey J, Connolly SJ. Atrial fibrillation after cardiac surgery: update on the evidence on the available prophylactic interventions. Card Electrophysiol Rev. 2003 Jun;7(2):189-92. doi: 10.1023/a:1027432104518.

  PMID: 14618049 BACKGROUND

• Crystal E, Garfinkle MS, Connolly SS, Ginger TT, Sleik K, Yusuf SS. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003611. doi: 10.1002/14651858.CD003611.pub2.

  PMID: 15495059 BACKGROUND

• Elahi M, Hadjinikolaou L, Galinanes M. Incidence and clinical consequences of atrial fibrillation within 1 year of first-time isolated coronary bypass surgery. Circulation. 2003 Sep 9;108 Suppl 1:II207-12. doi: 10.1161/01.cir.0000089188.45285.fd.

  PMID: 12970234 BACKGROUND

• Vicol C, Eifert S, Kur F, Reichart B. Minimally invasive off-pump pulmonary vein isolation to treat paroxysmal atrial fibrillation. Thorac Cardiovasc Surg. 2005 Jun;53(3):176-8. doi: 10.1055/s-2005-837527.

  PMID: 15926099 BACKGROUND

• Ishii Y, Schuessler RB, Gaynor SL, Yamada K, Fu AS, Boineau JP, Damiano RJ Jr. Inflammation of atrium after cardiac surgery is associated with inhomogeneity of atrial conduction and atrial fibrillation. Circulation. 2005 Jun 7;111(22):2881-8. doi: 10.1161/CIRCULATIONAHA.104.475194. Epub 2005 May 31.

  PMID: 15927979 BACKGROUND

• Stamou SC, Dangas G, Hill PC, Pfister AJ, Dullum MK, Boyce SW, Bafi AS, Garcia JM, Corso PJ. Atrial fibrillation after beating heart surgery. Am J Cardiol. 2000 Jul 1;86(1):64-7. doi: 10.1016/s0002-9149(00)00829-8.

  PMID: 10867094 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Bob Kiaii, MD, FRCSC

  Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 20, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

CA (1)