Left Atrial Appendage Occlusion Study III "LAAOS III"

Recruiting

Phase N/A Results N/A

Update History

10 Sep '16
The Summary of Purpose was updated.
New
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.
Old
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.
26 Aug '15
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: 1. Greater than 18 years of age 2. Undergoing a clinically indicated cardiac surgical procedure 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 - ventricular assist device insertion - re-operation - mechanical valve implant 3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device
23 Apr '13
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Greater than 18 years of age 2. Undergoing a clinically indicated cardiac surgical procedure 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 - ventricular assist device insertion - re-operation - mechanical valve implant 3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device
Old
Inclusion Criteria: 1. Greater than 18 years of age 2. Undergoing a clinically indicated cardiac surgical procedure 3. Have a documented history of atrial fibrillation or atrial flutter 4. 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 - ventricular assist device insertion - re-operation 3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device
10 Oct '12
The Summary of Purpose was updated.
New
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.
Old
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 3500 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.
A location was updated in Hamilton.
New
The overall status was updated to "Recruiting" at Hamilton General Hospital.