WATCHMAN Device for Atrial Fibrillation
(LAAOS-4 Trial)
Recruiting in Palo Alto (17 mi)
+31 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hamilton Health Sciences Corporation
Must be taking: Oral anticoagulants
Must not be taking: Direct thrombin inhibitors
Disqualifiers: Age < 18, Thrombus, Prior occlusion, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Will I have to stop taking my current medications?
The trial requires participants to continue taking their current oral anticoagulant medications (like Vitamin K agonists or factor Xa inhibitors) for the duration of the study.
What data supports the effectiveness of the WATCHMAN device treatment for atrial fibrillation?
The WATCHMAN device is designed to reduce the risk of stroke in patients with atrial fibrillation. The PREVAIL trial showed that the benefits of the WATCHMAN device outweigh the risks for patients who meet specific criteria, despite some concerns about ischemic strokes. The newer WATCHMAN FLX device has shown good procedural success and safety in small studies, with improvements in design to enhance performance and safety.
12345Is the WATCHMAN device safe for humans?
The WATCHMAN device has been studied for safety, with an overall adverse event rate of 7.3% and a mortality rate of 0.4% in a large study. Most issues occurred during or shortly after the procedure, but some serious events like strokes and device movement happened more than a month later. The newer WATCHMAN FLX device is designed to improve safety and has shown good results in smaller studies.
13467How does the WATCHMAN device treatment for atrial fibrillation differ from other treatments?
The WATCHMAN device is a unique treatment for atrial fibrillation as it is a small implant placed in the heart to prevent strokes by blocking the left atrial appendage, where blood clots often form. Unlike traditional blood-thinning medications, it offers an alternative for patients who are at high risk of bleeding complications from long-term anticoagulant use.
13489Eligibility Criteria
This trial is for adults with atrial fibrillation who are at high risk of stroke, even while on blood thinners. They should have a CHA2DS2-VASc score of 4 or more, indicating they're more likely to have a stroke. Participants must be willing to continue their current oral anticoagulant therapy throughout the study.Inclusion Criteria
You have a heightened risk of stroke, determined via the CHA2DS2-VASc score being equal to or greater than four.
I have ongoing or occasional atrial fibrillation and have had a stroke or blood clot.
I have been on blood thinners for at least 3 months and plan to continue.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo endovascular left atrial appendage occlusion with the WATCHMAN device or receive standard medical care
Procedure duration and immediate recovery
1 visit (in-person for procedure)
Follow-up
Participants are monitored for safety and effectiveness, including assessment of ischemic stroke or systemic embolism
4 years
Regular follow-up visits (frequency not specified)
Participant Groups
The LAAOS-4 study tests if using the WATCHMAN device can prevent strokes or blood clots in people with atrial fibrillation who still face high stroke risks despite taking blood thinners. The device is implanted through a catheter-based procedure.
2Treatment groups
Experimental Treatment
Active Control
Group I: WATCHMAN deviceExperimental Treatment1 Intervention
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Group II: Standard CareActive Control1 Intervention
Participants will receive local, standard medical care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Aultman HospitalCanton, OH
Texas Cardiac Arrhythmia Research FoundationAustin, TX
University of CalgaryCalgary, Canada
Circulate Cardiac & Vascular Centre (CCVC)Burlington, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Hamilton Health Sciences CorporationLead Sponsor
McMaster UniversityCollaborator
Population Health Research InstituteCollaborator
Boston Scientific CorporationIndustry Sponsor
References
Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy. [2015]The WATCHMAN left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with nonvalvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a "not approvable" letter was issued by the US Food and Drug Administration (FDA) based on safety concerns. Subsequently, the FDA, collaboratively with the sponsor, designed a new Prospective Randomized Evaluation of the WATCHMAN LAAC Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy (PREVAIL) trial to address the earlier study limitations. A second panel was convened in December 2013 to review the results of PREVAIL and additional long-term follow-up data from PROTECT AF. The second panel voted favorably 13 to 1 that the benefits of the WATCHMAN LAAC therapy do outweigh the risks for use in patients who meet the criteria specified in the proposed indication. Subsequently, and during the premarket approval review, updated data from the PREVIAL study revealed more ischemic strokes in the WATCHMAN group, corresponding to a total of 13 ischemic strokes in the WATCHMAN group versus 1 in the control group. As a result of these strokes, the FDA called for a third panel to assess the benefit-risk profile of the WATCHMAN device. This summary aims to describe the discussions and recommendations made during the panel meetings.
Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX.
Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry. [2023]The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting.
Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry. [2022]The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise.
Transition from WATCHMAN V.2.5 to WATCHMAN FLX for closure of the left atrial appendage: echocardiographic and clinical findings. [2023]Interventional closure of the left atrial appendage (LAAC) has been established as an alternative treatment for patients with atrial fibrillation (AF) and an elevated risk of stroke. The WATCHMAN FLX (WM FLX) as the newest WATCHMAN LAAC device differs in several technical characteristics from its precursor, the WATCHMAN V.2.5 (WM V.2.5).
Intracardiac echocardiography-guided implantation of the Watchman FLX left atrial appendage closure device. [2021]The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia.
MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device. [2021]Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.
Watchman FLX Implantation for Challenging Left Atrial Appendage Anatomy: Case-Based Discussion. [2022]Left atrial appendage (LAA) occlusion devices provided an acceptable and valid alternative to anticoagulation among patients with atrial fibrillation who carry high bleeding risk. Watchman device is non-inferior to oral anticoagulation to prevent cerebrovascular accidents. The presence of a longer distal portion of the older generation Watchman led to exclusion of patients with prohibitive anatomy of the LAA such as chicken-wing morphology or shallow LAA. Watchman FLX provides a wider range of sizes and can be implanted with complex anatomy or shallow LAA. In the case series, we discuss 3 patients with challenging LAA anatomy that underwent successful Watchman FLX implantation.
Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation. [2020]A concerning proportion of patients with atrial fibrillation (AF) with indications for oral anticoagulation (OAC) discontinue OAC or are never prescribed OAC therapy and many AF patients with the highest risk for embolic events off OAC also have the greatest risk for hemorrhagic complications on OACs. Medium-term efficacy and safety data provide evidence that the WATCHMAN device, the most studied device and the only one with randomized and medium-term follow-up data, may be a viable alternative to chronic warfarin therapy in nonvalvular AF patients. In addition to presenting key data pertaining to LAA closure techniques including the WATCHMAN device, this review will discuss crucial WATCHMAN implantation technical points.