Feasibility and Prognosis of Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation

• Conditions: Device Occlusion
• Interventions: Device: Left atrial appendage closure

• Registration Number: NCT04472871
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-14
• Last Update Submitted: 2020-07-14
• Study First Posted: 2020-07-16
• Last Update Posted: 2020-07-16
• Study Start: 2020-07-20
• Primary Completion: 2021-03-15
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• In this study,

  1. Atrial fibrillation patients with previous major bleeding.
  2. Atrial fibrillation patients with previous bleeding predisposition
  3. Atrial fibrillation patients with previous contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.

Exclusion Criteria

• Patients having no data for follow up after the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with atrial fibrillation without heart failure	Left atrial appendage closure	Patients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study
patients with atrial fibrillation and heart failure	Left atrial appendage closure	Patients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study

Primary Outcome Measures

Name	Time	Method
procedural success	6 weeks post procedure	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 study will assess the rate of procedural success in both groups of the study.
the absence of any complication related to the intervention	6 months post intervention	Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups.