TERMINATED

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

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Conditions

Atrial FibrillationGI Bleeding

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-23
Study Completion:2025-06-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06052358

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All male and female patients who are \> 18 years of age
  2. * Have Atrial Fibrillation
  3. * Have CHADS2VASc \> 2
  4. * 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.
  5. * Ability to understand study procedures and to comply with them for the entire length of the study.
  1. * Inability or unwillingness of individual to give written informed consent.
  2. * Other indications for OAC like deep vein thrombosis (DVT) or Pulmonary embolism (PE) or mechanical heart valve.
  3. * Patient who is pregnant will be excluded (Pregnancy will be excluded by checking urine beta-HCG).
  4. * Patient not following up with our practice / clinic after the procedure

Contacts and Locations

Principal Investigator

Dhanunjaya Lakkireddy, MD
PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute

Study Locations (Sites)

Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
United States
Research Medical Center Clinic
Kansas City, Missouri, 64032
United States
Research Medical Center
Kansas City, Missouri, 64032
United States

Collaborators and Investigators

Sponsor: Kansas City Heart Rhythm Research Foundation

  • Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

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 Registration Dates

Study Start Date2023-08-23
Study Completion Date2025-06-11

Study Record Updates

Study Start Date2023-08-23
Study Completion Date2025-06-11

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • GI Bleeding