Left Atrial Appendage Occlusion Study II

Stroke Clinical Trial

— LAAOSII  

Official title:

Phase III Pilot Study - Left Atrial Appendage Occlusion Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908700
• Other study ID #: LAAOSII
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2009
• Last updated: September 21, 2015
• Start date: August 2009
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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. Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?

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?

Description:

The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events.

LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Procedure:
• Surgical occlusion of the left atrial appendage
Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
• Best medical practice
Best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Population Health Research Institute	London Health Sciences Centre, McMaster University, Sunnybrook Health Sciences Centre, Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes