NCT00908700

Brief Summary

A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke. Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines. Main research questions:

  1. 1.Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
  2. 2.In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Aug 2009

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

May 26, 2009

Last Update Submit

September 21, 2015

Conditions

Atrial FibrillationStroke

Keywords

Atrial fibrillationStrokeleft atrial appendageRe-exploration for bleeding

Outcome Measures

Primary Outcomes (1)

  • Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.

    Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)

Secondary Outcomes (1)

  • Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding.

    Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)

Study Arms (2)

Occlusion arm

EXPERIMENTAL

Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.

Procedure: Surgical occlusion of the left atrial appendage

Medical arm

ACTIVE COMPARATOR

Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Procedure: Best medical practice

Interventions

Surgical occlusion of the left atrial appendagePROCEDURE

Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.

Occlusion arm
Best medical practicePROCEDURE

Best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Medical arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass
  • A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:
  • age =\> 65 years
  • hypertension
  • diabetes mellitus, or
  • heart failure/left ventricular ejection fraction \< 50%

You may not qualify if:

  • Patients in whom surgical AF ablation (MAZE or otherwise) is planned
  • Planned "off-pump" surgery
  • Planned implantation of a mechanical valve
  • Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Richard Whitlock, MD, FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Surgeon, Department of Surgery

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2012

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

CA(1)