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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052358
• Other study ID #: KCHRRF_GI FLX_0022
• Status: Recruiting
• Start date: August 23, 2023
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: Datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

A large gap in the literature exists as no prior study has evaluated the outcomes of those with prior GI bleeding undergoing LAAC. Furthermore, patients with prior GI bleed may be on no or minimal antithrombotic therapy prior to LAAC and subsequently require escalation of antithrombotic therapy following LAAC. Long-term outcomes including bleeding events will be most relevant and informative to this potentially high-risk subgroup. Therefore, this is an attempt to create a prospective registry describing outcomes of patients with AF and prior GI bleed undergoing LAAC to provide insight into safety and efficacy and will also compare to a historical cohort of patients with AF and GI bleed without LAAC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Gastrointestinal Hemorrhage
• GI Bleeding
• Hemorrhage

Intervention

Device:
• LAAC with Watchman FLX device
LAAC with Watchman FLX device

Locations

Country	Name	City	State
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center Clinic	Kansas City	Missouri
United States	Kansas City Heart Rhythm Institute - Roe Clinic	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas

Sponsors (5)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Centennial Medical Center, Nashville, Tennessee, Kansas City Heart Rhythm Institute, Overland Park, Kansas, Los Robles Health System, Los Robles, California, Texas Cardiac Arrythmia Institute, Austin, Texas

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Erratum In: JAMA Cardiol. 2021 Oct 20;: — View Citation

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

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. Erratum In: J Am Coll Cardiol. 2014 Sep 16;64(11):1186. — View Citation

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. Erratum In: Lancet. 2009 Nov 7;374(9701):1596. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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 will be evaluated.	45 Days, 6 Months and 12 Months
Secondary	Number of days or hours of Hospital stay	If any participants are hospitalized, their Hospital length of stay will be evaluated.	45 Days, 6 Months and 12 Months