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

September 26, 2023 updated by: Kansas City Heart Rhythm Research Foundation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Recruiting
        • Overland Park Regional Medical Center
        • Contact:
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Heart Rhythm Institute - Roe Clinic
        • Principal Investigator:
          • Dhanunjaya Lakkireddy, MD
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64032
        • Recruiting
        • Research Medical Center Clinic
        • Contact:
      • Kansas City, Missouri, United States, 64032
        • Recruiting
        • Research Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 12 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 45 Days, 6 Months and 12 Months
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
Number of days or hours of Hospital stay
Time Frame: 45 Days, 6 Months and 12 Months
If any participants are hospitalized, their Hospital length of stay will be evaluated.
45 Days, 6 Months and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Collaborators

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

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRRF_GI FLX_0022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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