Examine whether closure of the left atrial appendage is associated with reduced stroke risk in patients with atrial fibrillation undergoing cardiac surgery
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
number of strokes
Secondary outcome
1. Mortality
2. post-operative safety outcomes: chest tube output in the first 24 hours
post-surgery, post-operative re-exploration for bleeding within 48 hours, and
30-day mortality
3. incidence of re-hospitalization for heart failure
4. incidence of major bleeding
5. incidence of myocardial infarction
Background summary
Atrial fibrillation is an important cause of ischemic stroke. Most strokes in
patients with AF arise from the left atrial appendage. If a patient with a
history of AF needs to undergo cardiac surgery, the left atrial appendage can
be removed. By doing so, an important source of thrombo-embolic complications
can be annihilated. Until now, it is not known whether this should be
considered as a standard procedure since it has never been proven that this
will reduce the stroke rate in the longterm.
Study objective
Examine whether closure of the left atrial appendage is associated with reduced
stroke risk in patients with atrial fibrillation undergoing cardiac surgery
Study design
International multi-centre double-blinded randomized controlled trial
Intervention
closure of left atrial appendage during surgery
Study burden and risks
Closure of the left atrial appendage during surgery conveys a risk of bleeding.
Closure of the appendage in addition to cardiac surgery will extend the
operation time by approximately 15-30 minutes.
Not closing the left atrial appendage during surgery will pose the patient to a
life time risk of stroke as the appendage is the most important source of
trombo-embolism in patients with atrial fibrillation.
Barton Street East, 237
DBCVSRI, Hamilton, Ontario, L8L 2X2
CA
Barton Street East, 237
DBCVSRI, Hamilton, Ontario, L8L 2X2
CA
Listed location countries
Age
Inclusion criteria
Patients with atrial fibrillation undergoing cardiac surgery
Exclusion criteria
Off-pump cardiac surgery
previous cardiac surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01561651 |
| CCMO | NL40885.099.12 |