Recruiting

Observational Study

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT06075628

Conditions

Atrial Fibrillation

Ischemic Stroke, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Left Atrial Appendage Occlusion

Study Details

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

Study ID

NCT06075628

Start date

Jul 24, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No definite exclusion criteria are defined for the study as all patients with Watchman-FLX or Amplatzer Amulet will be included in the study.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Amplatzer Amulet

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

Watchman / Watchman FLX

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

Interventions

Left Atrial Appendage Occlusion

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.

Primary outcome measure

  • 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 [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Kansas City Heart Rhythm Institute

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Dhanunjaya Lakkireddy, MD

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2025-08-28.