Atrial FibrillationNCT06052358
Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry
An observational study of Atrial Fibrillation and GI Bleeding, run by Kansas City Heart Rhythm Research Foundation at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, GI Bleeding
- What is being tested?
- LAAC with Watchman FLX device
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Aug 2023to 11 Jun 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Medical Center Clinic
Kansas City, Missouri, 64032
Research Medical Center
Kansas City, Missouri, 64032
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, GI Bleeding
- Being tested
- LAAC with Watchman FLX device
- Medical subject headings
- Atrial Fibrillation, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAAC with Watchman FLX deviceDevice
LAAC with Watchman FLX device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 45 Days, 6 Months and 12 Months
Number of days or hours of Hospital stay
If any participants are hospitalized, their Hospital length of stay will be evaluated.
Measured: 45 Days, 6 Months and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start23 Aug 2023
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Why it stopped: The study has been closed by the Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute, Texas Cardiac Arrythmia Institute, Austin, Texas, Los Robles Health System, Los Robles, California, Centennial Medical Center, Nashville, Tennessee
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052358
- Sponsor's protocol ID
- KCHRRF_GI FLX_0022
- Status last verified
- Aug 2025
- First submitted
- 18 Sep 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG- 00445N). Washington, DC: Centers for Medicare & Medicaid Services, 2016. In.
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.
PubMed 19683639Holmes 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.
PubMed 24998121Darden 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.
PubMed 34379072
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Closure With WATCHMAN FLX Device in Recurrent Gastrointestinal Bleeding: The GI-FLX Registry
- ClinicalTrials.gov ID
- NCT06052358
- Acronym / sponsor ID
- KCHRRF_GI FLX_0022
- Conditions
- Atrial Fibrillation, GI Bleeding
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study has been closed by the Sponsor.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute, Texas Cardiac Arrythmia Institute, Austin, Texas, Los Robles Health System, Los Robles, California, Centennial Medical Center, Nashville, Tennessee
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a history of AF and GI bleeding who will undergo LAAC | – | Device: LAAC with Watchman FLX deviceThis is group of patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAAC with Watchman FLX deviceLAAC with Watchman FLX device | Device | Patients with a history of AF and GI bleeding who will undergo LAAC |
Primary outcome
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
2 secondary outcomes
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 days or hours of Hospital stay
Time frame: 45 Days, 6 Months and 12 Months
Results and safety
The study was stopped early (reason given: The study has been closed by the Sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- BackgroundDecision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG- 00445N). Washington, DC: Centers for Medicare & Medicaid Services, 2016. In.
- Background: PubMed 19683639Holmes 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.
- Background: PubMed 24998121Holmes 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.
- Background: PubMed 34379072Darden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Heart Rhythm Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and GI Bleeding, run by Kansas City Heart Rhythm Research Foundation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study has been closed by the Sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06052358, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.