Device Occlusion Clinical Trial
Official title:
Feasibility and Prognostic Role of Percutaneous Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation at High Risk for Cerebrovascular Events
Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left
atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher
rate of stroke and embolism are observed even on oral anticoagulants.
Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an
impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to
assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with
heart failure in preventing thromboembolic events, bleeding and all-cause mortality.
Patients will be divided into to groups, one group includes patients with no evidence of
heart failure, and another group including patients with previous history of or with an
evidence of with heart failure.
Patients selection All patients underwent left atrial appendage closure in Assiut university
in the period from January 2014 to December 2019 will be included.
Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with
previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants
scheduled for transcatheter left atrial appendage closure are included.
Methods In this retrospective cohort study
1. All patients with previous major bleeding or a bleeding predisposition scheduled for
transcatheter LAAC in Assiut university in the period from January 2014 to December 2019
will be included.
2. All devices used in for LAAC in this period will be included (WATCHMAN, Amulet, LARIAT
and Lambre)
3. CHA2DS2-VASC, CHADS, HAS-BLED scores will be calculated for all patients.
4. Patients will be divided into to groups, one group includes patients with no evidence of
heart failure, and another group including patients with previous history of or with an
evidence of with heart failure.
5. Heart failure will be defined as patients with left ventricular ejection fraction ≤ 35%.
6. New York Heart Association (NYHA) classification will be determined for all patient
graded from I-IV.
7. Both groups will be compared regarding procedural success (Procedural success is defined
as deployment and release of the left atrial appendage closure device into the LAA with
peri-device leak < 5 mm), the absence of any complication related to the intervention,
major and minor bleeding, all-cause mortality and efficacy of the device to prevent
stroke, transient ischemic attack, systemic embolization during follow-up.
8. Device related thrombus (DRT) will be compared in both groups according to the results
of transesophageal echo (TOE) 6 weeks post procedure.
Primary endpoint
- The primary endpoints of the study are procedural success (Procedural success is defined as
deployment and release of the left atrial appendage closure device into the LAA with
peri-device leak < 5 mm), the absence of any complication related to the intervention,
bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient
ischemic attack, systemic embolization during follow-up in both groups of patients with heart
failure and without heart failure.
;