Clinical trial NCT01561651: Left Atrial Appendage Occlusion Study III
Official title: Left Atrial Appendage Occlusion Study III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery With Cardiopulmonary Bypass
Atrial Fibrillation
Keywords: cardiac surgery
left atrial appendage
atrial fibrillation
stroke
non-CNS systemic embolism
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 4812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as coumadin. Although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. The left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with AF. This structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. However, there is currently no strong evidence that removing it works.

The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF undergoing heart surgery for other reasons to have the left atrial appendage removed or not. These patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. The full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. A positive study will change the way heart surgery is performed on AF patients and results in a large reduction in the number of strokes in a large population. Further, it will promote further research into this approach that could be applied beyond AF patients undergoing heart surgery.


Eligibility criteria: Inclusion Criteria:

1. Greater than 18 years of age
2. Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass
3. Have a documented history of atrial fibrillation or atrial flutter
4. CHA2DS2-VASc score ≥ 2
5. Have provided informed consent

Exclusion Criteria:

1. Patients undergoing off-pump cardiac surgery
2. Patients undergoing any of the following procedures:

   * heart transplant
   * complex congenital heart surgery
   * sole indication for surgery is ventricular assist device insertion
   * previous cardiac surgery requiring opening of the pericardium
   * mechanical valve implant
3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device

Primary outcomes:
measure: Stroke or systemic arterial embolism
timeFrame: Common termination point (median follow-up of 4 years)
Secondary outcomes:
measure: All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism
timeFrame: Common termination point (median follow-up of 4 years)
measure: Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death
timeFrame: Common termination point (median follow-up of 4 years)
measure: Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism > 30 days after surgery
timeFrame: Common termination point (median follow-up of 4 years)
measure: Total mortality
timeFrame: Common termination point (median follow-up of 4 years)
Other outcomes:
measure: Readmission for heart failure
timeFrame: Common termination point (median follow-up of 4 years)
measure: Post-operative safety outcomes
timeFrame: 30 days post-surgery
measure: Major bleeding
timeFrame: Common termination point (median follow-up of 4 years)
measure: Myocardial infarction
timeFrame: Common termination point (median follow-up of 4 years)
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute/McMaster University
name: Richard Whitlock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute/McMaster University
name: Stuart Connolly, MD, PhD
role: STUDY_CHAIR
References:
citation: Whitlock RP, Belley-Cote EP, Paparella D, Healey JS, Brady K, Sharma M, Reents W, Budera P, Baddour AJ, Fila P, Devereaux PJ, Bogachev-Prokophiev A, Boening A, Teoh KHT, Tagarakis GI, Slaughter MS, Royse AG, McGuinness S, Alings M, Punjabi PP, Mazer CD, Folkeringa RJ, Colli A, Avezum A, Nakamya J, Balasubramanian K, Vincent J, Voisine P, Lamy A, Yusuf S, Connolly SJ; LAAOS III Investigators. Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke. N Engl J Med. 2021 Jun 3;384(22):2081-2091. doi: 10.1056/NEJMoa2101897. Epub 2021 May 15.