Atrial FibrillationPhase 3LAAOSIINCT00908700
Left Atrial Appendage Occlusion Study II
A Phase 3 study testing Surgical occlusion of the left atrial appendage and Best medical practice in people with Atrial Fibrillation and Stroke, run by Population Health Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Surgical occlusion of the left atrial appendage and Best medical practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Pilot Study - Left Atrial Appendage Occlusion Study
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.
Read more
Main research questions:
- Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
- 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?
Read the detailed 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.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Surgical occlusion of the left atrial appendage, Best medical practice
- Keywords
- Atrial fibrillation, Stroke, left atrial appendage, Re-exploration for bleeding
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical occlusion of the left atrial appendageProcedure or surgery
Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
Best medical practiceProcedure or surgery
Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Occlusion arm | Experimental | Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion. Receives: 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. Receives: Procedure: Best medical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.
Measured: 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.
Measured: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Sunnybrook Health Sciences Centre, London Health Sciences Centre, Université de Montréal
- Responsible party
- Principal investigator, Richard Whitlock, Population Health Research Institute
- Investigators
- Richard Whitlock, MD, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908700
- Sponsor's protocol ID
- LAAOSII
- Acronym
- LAAOSII
- Status last verified
- Sep 2015
- First submitted
- 26 May 2009
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Pilot Study - Left Atrial Appendage Occlusion Study
- ClinicalTrials.gov ID
- NCT00908700
- Acronym / sponsor ID
- LAAOSII / LAAOSII
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Atrial fibrillation, Stroke, left atrial appendage, Re-exploration for bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- McMaster University, Sunnybrook Health Sciences Centre, London Health Sciences Centre, Université de Montréal
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
- 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?
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusion arm | Experimental | Procedure: Surgical occlusion of the left atrial appendageSurgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion. |
| Medical arm | Active comparator | Procedure: Best medical practiceMedical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical occlusion of the left atrial appendageStudy intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device. | Procedure or surgery | Occlusion arm |
| Best medical practiceBest medical practice for atrial fibrillation related stroke prevention as per guidelines. | Procedure or surgery | Medical arm |
Primary outcome
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.
Time frame: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
1 secondary outcome
Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding.
Time frame: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Whitlock, MD, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgical occlusion of the left atrial appendage and Best medical practice in people with Atrial Fibrillation and Stroke, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication. (time frame: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015; AzTrials last refreshed its copy on 28 Oct 2026.