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

NCT04472871 | Unknown DMC FDA Device

• 1 other identifier: LAA closure in heart failure
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Device Occlusion

Outcome Measures

Primary Outcomes (2)

• procedural success

  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.

  6 weeks post procedure

• the absence of any complication related to the 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.

  6 months post intervention

Study Arms (2)

patients with atrial fibrillation and heart failure

Patients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study

Device: Left atrial appendage closure

patients with atrial fibrillation without heart failure

Patients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study

Device: Left atrial appendage closure

Interventions

Left atrial appendage closure DEVICE

The left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel.

patients with atrial fibrillation and heart failure; patients with atrial fibrillation without heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included. In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants who were scheduled for transcatheter left atrial appendage closure are included

You may qualify if:

• In this study,
• Atrial fibrillation patients with previous major bleeding.
• Atrial fibrillation patients with previous bleeding predisposition
• Atrial fibrillation patients with previous contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.

You may not qualify if:

• Patients having no data for follow up after the procedure

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.

  PMID: 23325525 RESULT

• Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025.

  PMID: 26088300 RESULT

• Saw J. Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman. J Am Coll Cardiol. 2017 Dec 19;70(24):2976-2978. doi: 10.1016/j.jacc.2017.10.056. Epub 2017 Nov 2. No abstract available.

  PMID: 29104013 RESULT

• Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.

  PMID: 29103847 RESULT

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

  PMID: 27567408 RESULT

• Ellis CR, Kanagasundram AN. Atrial Fibrillation in Heart Failure: Left Atrial Appendage Management. Cardiol Clin. 2019 May;37(2):241-249. doi: 10.1016/j.ccl.2019.01.009. Epub 2019 Feb 13.

  PMID: 30926025 RESULT

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Mohamed A Osman, Ass. lect.

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed A Osman, Ass. lect.

CONTACT

01061878040; mosman87@gmail.com

Hosam H Aly, Prof

CONTACT

01223971327; hosam_hasan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 16, 2020
• Study Start: July 20, 2020
• Primary Completion: March 15, 2021
• Study Completion: July 1, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share