The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT06052358
Recruitment Status : **RECRUITING NOW**
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
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
Information provided by (Responsible Party):
Kansas City Heart Rhythm Research Foundation
Study Description
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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.
Condition or disease
Intervention/treatment
Atrial Fibrillation GI Bleeding
Device: LAAC with Watchman FLX device
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 Design
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Study Type :
Observational [Patient Registry]
Estimated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Target Follow-Up Duration:
12 Months
Official Title:
Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry
Actual Study Start Date :
August 23, 2023
Estimated Primary Completion Date :
August 2025
Estimated Study Completion Date :
August 2025
Resource links provided by the National Library of Medicine
Groups and Cohorts
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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.
Outcome Measures
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Primary Outcome Measures :
To evaluate baseline characteristics [ Time Frame: 12 Months ]
To evaluate baseline characteristics such as Primary systemic thromboembolism (STE)/stroke, Recurrent bleeding after initial period of oral anticoagulant (OAC) requiring blood transfusion or hospitalization and Hemorrhagic stroke
Secondary Outcome Measures :
Complications [ Time Frame: 45 Days, 6 Months and 12 Months ]
Peri-device leaks (PDL)
Complications [ Time Frame: 45 Days, 6 Months and 12 Months ]
Device related thrombosis (DRT) related to WATCHMAN-FLX, Minor bleeding episodes leading to hospital visit but no transfusion, Incidence of hospitalization and Mortality at 12 months
Complications [ Time Frame: 45 Days, 6 Months and 12 Months ]
If hospitalized, Hospital length of stay
Eligibility Criteria
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
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.
Criteria
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
Contacts and Locations
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052358
Contacts
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Contact: Donita Atkins
816-651-1969
Datkins@kchrf.com
Locations
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United States, Kansas
Kansas City Heart Rhythm Institute – Roe Clinic
**RECRUITING NOW**
Overland Park, Kansas, United States, 66211
Contact: Donita Atkins   816-651-1969   Datkins@kchrf.com  Â
Principal Investigator: Dhanunjaya Lakkireddy, MD Â Â Â Â Â Â
Overland Park Regional Medical Center
**RECRUITING NOW**
Overland Park, Kansas, United States, 66215
Contact: Donita Atkins   816-651-1969   Datkins@kchrf.com  Â
United States, Missouri
Research Medical Center Clinic
**RECRUITING NOW**
Kansas City, Missouri, United States, 64032
Contact: Donita Atkins   816-651-1969   Datkins@kchrf.com  Â
Research Medical Center
**RECRUITING NOW**
Kansas City, Missouri, United States, 64032
Contact: Donita Atkins   816-651-1969   Datkins@kchrf.com  Â
Sponsors and Collaborators
Kansas City Heart Rhythm Research Foundation
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
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Principal Investigator:
Dhanunjaya Lakkireddy, MD
Kansas City Heart Rhythm Institute
More Information
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Publications:
Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG- 00445N). Washington, DC: Centers for Medicare & Medicaid Services, 2016. In.
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;:
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Responsible Party:
Kansas City Heart Rhythm Research Foundation
ClinicalTrials.gov Identifier:
NCT06052358 Â Â
Other Study ID Numbers:
KCHRRF_GI FLX_0022
First Posted:
September 25, 2023 Â Â Key Record Dates
Last Update Posted:
September 25, 2023
Last Verified:
September 2023
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
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Gastrointestinal HemorrhageAtrial FibrillationHemorrhageArrhythmias, CardiacHeart Diseases
Cardiovascular DiseasesPathologic ProcessesGastrointestinal DiseasesDigestive System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
