Long-Term Outcomes of LAA Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry

NCT06075628 | Recruiting

• 1 other identifier: KCHRRF_CF-CT Registry_0021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to assess the incidence and correlation to the development of peri-device leaks (PDLs), device related thrombosis (DRTs) and cerebral vascular accident (CVA)/transient ischemic attacks (TIAs) in association with left atrial appendage contrast flow (LAA-CF). It will be a multi-center, retrospective study. Approximately 100 subject charts will be reviewed.

Conditions

Atrial Fibrillation; Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Incidence and correlation to the development of Peri-Device Leak (PDLs), Device-Related Thrombus (DRT) or cerebral vascular accident (CVA) in association with LAA-CF

  Incidence and correlation to the development of PDLs, DRTs or CVA in association with LAA-CF will be assessed. These will be noted as either Yes or No.

  12 Months

Secondary Outcomes (3)

• Total time to complete endothelization or no LAA-CF

  12 Months

• Association of device size with LAA-CF

  12 Months

• Association of landing zone with LAA-CF

  12 Months

Study Arms (2)

Amplatzer Amulet

This is the group of subjects who are implanted with Amplatzer Amulet device.

Other: Left Atrial Appendage Occlusion

Watchman / Watchman FLX

This is the group of subjects who are implanted with Watchman / Watchman FLX device.

Other: Left Atrial Appendage Occlusion

Interventions

Left Atrial Appendage Occlusion OTHER

Acute ischemic stroke is a major cause of morbidity and mortality in non-valvular Atrial Fibrillation (AF). Oral Anticoagulation (OAC) with Warfarin and Direct oral anticoagulants (DOACs) has been the mainstay to prevent systemic thromboembolism (STE) in this patient population. It is estimated that around 50% of patients who have AF with indication for OAC end up being not on OAC due to bleeding complications leaving them at high risk for developing STE. Left atrial appendage occlusion (LAAO) offers an option in such population.

Amplatzer Amulet; Watchman / Watchman FLX

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

Charts of all subjects who underwent LAA closure either with Watchman/Watchman FLX or Amplatzer Amulet device from January 2019 till June 2022 will be reviewed. Chart review will be performed up to 1 year, after the patient is discharged from the hospital.

You may qualify if:

• Subjects must be at least 18 years of age.
• Subjects underwent LAA closure with Watchman/Watchman FLX or Amplatzer Amulet at our institution from January 2019 till June 2022

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (1)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

RECRUITING

Related Publications (6)

• Dar T, Yarlagadda B, Vacek J, Dawn B, Lakkireddy D. Management of Stroke risk in atrial fibrillation patients with bleeding on Oral Anticoagulation Therapy-Role of Left Atrial Appendage Closure, Octreotide and more. J Atr Fibrillation. 2017 Dec 31;10(4):1729. doi: 10.4022/jafib.1729. eCollection 2017 Dec.

  PMID: 29487685 BACKGROUND

• Viles-Gonzalez JF, Kar S, Douglas P, Dukkipati S, Feldman T, Horton R, Holmes D, Reddy VY. The clinical impact of incomplete left atrial appendage closure with the Watchman Device in patients with atrial fibrillation: a PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) substudy. J Am Coll Cardiol. 2012 Mar 6;59(10):923-9. doi: 10.1016/j.jacc.2011.11.028.

  PMID: 22381428 BACKGROUND

• Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.

  PMID: 24998121 BACKGROUND

• Meier B, Blaauw Y, Khattab AA, Lewalter T, Sievert H, Tondo C, Glikson M; Document Reviewers. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. Europace. 2014 Oct;16(10):1397-416. doi: 10.1093/europace/euu174. Epub 2014 Aug 29. No abstract available.

  PMID: 25172844 BACKGROUND

• Lim YM, Kim JS, Kim TH, Uhm JS, Shim CY, Joung B, Hong GR, Lee MH, Jang YS, Pak HN. Delayed left atrial appendage contrast filling in computed tomograms after percutaneous left atrial appendage occlusion. J Cardiol. 2017 Dec;70(6):571-577. doi: 10.1016/j.jjcc.2017.04.007. Epub 2017 May 22.

  PMID: 28546017 BACKGROUND

• Whitlock RP, Healey JS, Holmes DR. Left atrial appendage occlusion debate revisited. Circulation. 2015 Feb 24;131(8):756-61. doi: 10.1161/CIRCULATIONAHA.114.008840. No abstract available.

  PMID: 25712058 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: July 24, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (1)