CLAAS Device for Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
+62 other locations
Overseen byWilliam Gray, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Conformal Medical, Inc
Must not be taking: Antiplatelets, Anticoagulants
Disqualifiers: Pregnancy, Infection, Stroke, Heart failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new heart device called the CLAAS® to see if it works as well as other similar devices. It is aimed at patients with a specific type of irregular heartbeat that can lead to strokes. The device helps by blocking off a small part of the heart to stop blood clots from forming.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you must be suitable for short-term oral anticoagulation therapy and less favorable for long-term anticoagulation therapy.
Is the CLAAS device for atrial fibrillation safe for humans?
The CLAAS device, similar to the WATCHMAN and Amulet devices, is used for closing the left atrial appendage in the heart. While specific safety data for CLAAS is limited, studies on similar devices like WATCHMAN and Amulet suggest they are generally safe, with some risks of leaks that are monitored after the procedure.
12345How is the CLAAS device treatment for atrial fibrillation different from other treatments?
The CLAAS device is unique because it uses a conformable foam-based design to seal the left atrial appendage, which may offer better adaptability and fit compared to other devices like the WATCHMAN or Amulet. This design aims to improve the effectiveness of stroke prevention in patients with atrial fibrillation who cannot use blood thinners.
24678Eligibility Criteria
Adults over 18 with non-valvular atrial fibrillation at high risk for stroke (CHADS2 >2 or CHA2DS2-VASc ≥3) who can't take long-term oral anticoagulants but can handle short-term use. Excludes those with recent strokes, severe heart failure, general anesthesia issues, life expectancy under 5 years, pregnancy plans within a year, certain allergies or conditions that affect device placement.Inclusion Criteria
I am at high risk for stroke or blood clots.
The patient (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)
The site doctor and another doctor agree that closing the left atrial appendage is the right choice for you, and they make this decision together based on standard medical practices.
+5 more
Exclusion Criteria
I have a heart condition that requires closing a hole in my heart.
I cannot undergo certain heart imaging tests due to my condition.
My heart's pumping ability is severely reduced.
+26 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the CLAAS device or the WATCHMAN/Amulet devices for left atrial appendage occlusion
Procedure day
1 visit (in-person)
Initial Follow-up
Participants are monitored for safety endpoints including myocardial infarction and neurologic events
45 days
2 visits (in-person)
Extended Follow-up
Participants are monitored for primary and secondary endpoints including ischemic stroke, systemic embolism, and closure success
18 months
Regular visits (in-person)
Long-term Follow-up
Participants are followed for safety and effectiveness for 5 years after device implant
5 years
Participant Groups
The trial is testing the CLAAS device against existing WATCHMAN and Amulet devices for closing the left atrial appendage in patients with atrial fibrillation to prevent strokes. Participants are randomly chosen to receive one of these devices and will be monitored for five years.
2Treatment groups
Experimental Treatment
Active Control
Group I: CLAASExperimental Treatment1 Intervention
Transcatheter left atrial occluder
Group II: WATCHMAN / AmuletActive Control1 Intervention
Transcatheter left atrial occluder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Arkansas for Medical SciencesLittle Rock, AR
Morristown Medical CenterMorristown, NJ
Lankenau Heart InstituteWynnewood, PA
Ascension St. John's HospitalDetroit, MI
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Conformal Medical, IncLead Sponsor
References
Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia. [2019]Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width
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.
Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience. [2022]Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry.
Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use. [2022]The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.
Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. [2022]Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The "Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.
Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device. [2022]Left atrial appendage (LAA) occlusion has been established as an alternative to systemic anticoagulation for stroke prevention in patients with atrial fibrillation; however, limitations of current devices have slowed adoption. We present preclinical evaluations of a novel device, the Conformal Left Atrial Appendage Seal (CLAAS).
Amplatzer Amulet™ left atrial appendage occluder: A step-by-step guide to device implantation. [2022]Recently receiving Food and Drug Administration approval, the Amplatzer Amulet™ left atrial appendage occluder device (Abbott Medical Inc.) provides a dual seal mechanism alternative to the commercially available Watchman FLX or Watchman 2.5 device for embolic stroke prevention in patients with nonvalvular atrial fibrillation. This step-by-step review will cover patient selection, preprocedure imaging assessment, device sizing, device preparation, implant target position assessment, implant technique and troubleshooting, and immediate postimplant follow-up.
[Left Atrial Appendage Closure - step by step]. [2021]Thrombus formation due to atrial fibrillation is the most common cause of embolic stroke. Anticoagulation offers an effective prophylaxis. However, anticoagulation in turn has an inherent increased risk of bleeding. Patients with non-valvular atrial fibrillation who have contraindications for anticoagulation may profit from a closure of the left atrial appendage. The most commonly and best studied devices for this are the WATCHMAN™ and the AMPLATZER Amulet™ Occluders.In this How-To article, the aim is to offer a general overview of the indications, contraindications and complications as well as the implantation and postoperative management of patients receiving LAA closure by example of the WATCHMAN FLX™ Occluder.