Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry

NCT06052358 | Terminated FDA Device

• 1 other identifier: KCHRRF_GI FLX_0022
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

The GI-FLX Registry is intended to create a registry of patients with a history of Atrial Fibrillation (AF) and Gastrointestinal (GI) bleed who will receive Left Atrial Appendage Closure (LAAC) with WATCHMAN FLX device and compare to patients with AF and GI bleed who do not have LAAC. The GI-FLX Registry will be a multi-center, non-randomized registry. Approximately 250 prospective patients will be enrolled at all 4 sites. Historical cohort of 250 patients after propensity score matching with WATCHMAN-FLX arm will be included in the final analysis.

Conditions

Atrial Fibrillation; GI Bleeding

Outcome Measures

Primary Outcomes (1)

• Number of participants with Primary systemic thromboembolism (STE)/stroke, Recurrent bleeding after initial period of oral anticoagulant (OAC) requiring blood transfusion or hospitalization and Hemorrhagic stroke

  Baseline characteristics of participants such as Primary systemic thromboembolism (STE)/stroke, Recurrent bleeding after initial period of oral anticoagulant (OAC) requiring blood transfusion or hospitalization and Hemorrhagic stroke will be evaluated

  12 Months

Secondary Outcomes (2)

• Number of participants with complications such as Peri-device leaks (PDL), Device related thrombosis (DRT), Minor bleeding episodes leading to hospital visit but no transfusion, Incidence of hospitalization and Mortality

  45 Days, 6 Months and 12 Months

• Number of days or hours of Hospital stay

  45 Days, 6 Months and 12 Months

Study Arms (2)

Patients with a history of AF and GI bleeding who will undergo LAAC

This is group of patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed.

Device: LAAC with Watchman FLX device

Patients with a history of AF and GI bleeding without LAAC

This is a historical cohort of patients with AF and recurrent GI bleeding without LAAC.

Interventions

LAAC with Watchman FLX device DEVICE

LAAC with Watchman FLX device

Patients with a history of AF and GI bleeding who will undergo LAAC

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

Approximately 250 patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed will be enrolled. This group will be compared to a historical cohort group of 250 patients with AF and recurrent gastrointestinal bleeding without LAAC.

You may qualify if:

• All male and female patients who are \> 18 years of age
• Have Atrial Fibrillation
• Have CHADS2VASc \> 2
• Have history of GI bleeding OR hospital admission that required blood transfusion OR emergency room visit requiring stopping of OAC OR outpatient 2 gm of Hgb drop from baseline, with or without evidence of upper or lower GI bleeding and requiring endoscopic procedure with holding of OAC.
• Ability to understand study procedures and to comply with them for the entire length of the study.

You may not qualify if:

• Inability or unwillingness of individual to give written informed consent.
• Other indications for OAC like deep vein thrombosis (DVT) or Pulmonary embolism (PE) or mechanical heart valve.
• Patient who is pregnant will be excluded (Pregnancy will be excluded by checking urine beta-HCG).
• Patient not following up with our practice / clinic after the procedure

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead
• Kansas City Heart Rhythm Institute, Overland Park, Kansas: collaborator
• Texas Cardiac Arrythmia Institute, Austin, Texas: collaborator
• Los Robles Health System, Los Robles, California: collaborator
• Centennial Medical Center, Nashville, Tennessee: collaborator

Study Sites (4)

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

Location

Research Medical Center

Kansas City, Missouri, 64032, United States

Location

Related Publications (4)

• Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG- 00445N). Washington, DC: Centers for Medicare & Medicaid Services, 2016. In.

  BACKGROUND

• Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.

  PMID: 19683639 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

• Darden D, Duong T, Du C, Munir MB, Han FT, Reeves R, Saw J, Zeitler EP, Al-Khatib SM, Russo AM, Minges KE, Curtis JP, Freeman JV, Hsu JC. Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry. JAMA Cardiol. 2021 Nov 1;6(11):1275-1284. doi: 10.1001/jamacardio.2021.3021.

  PMID: 34379072 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: August 23, 2023
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (4)