CLAAS Device for Atrial Fibrillation

Recruiting at 68 trial locations

Overseen By Aly Dechert, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Conformal Medical, Inc

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Infection, Stroke, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Procedure day

1600 Participants Needed

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. ^{1 2 3 4 5}

How 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. ^{2 4 6 7 8}

Research Team

William Gray, M.D.

Principal Investigator

Lankenau Heart Institute

Shephal Doshi, M.D.

Principal Investigator

Pacific Heart Institute

Eligibility 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.

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.

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

Treatment Details

Interventions

• CLAAS
• Conformal Left Atrial Appendage Seal
• WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

Trial Overview 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.

Participant Groups

Group I: CLAAS Experimental Treatment 1 Intervention

Transcatheter left atrial occluder

Group II: WATCHMAN / Amulet Active Control 1 Intervention

Transcatheter left atrial occluder

Who Is Running the Clinical Trial?

Conformal Medical, Inc

Lead Sponsor

Trials

5

Recruited

2,100+

Findings from Research

In a study of 32 patients with a maximal left atrial appendage (LAA) ostial width of less than 17 mm, LAA closure using the WATCHMAN device was successfully performed in 97% of cases without any major complications.

Follow-up transesophageal echocardiograms showed no significant leaks or device-related thrombi, indicating that the procedure is both safe and effective for patients with smaller LAA ostial widths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia. Venkataraman, G., Strickberger, SA., Doshi, S., et al.[2019]

The Watchman-FLX left atrial appendage closure device demonstrated a high procedural success rate of 99.5% in a high-risk population of 200 patients, with no reported device embolizations and a low complication rate of 8.5%.

Key advantages of the Watchman-FLX include its ease of implantation and repositioning, effective sealing of the left atrial appendage, and a significantly lower failure rate compared to the first-generation Watchman device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry. Vizzari, G., Grasso, C., Sardone, A., et al.[2022]

The Amulet LAAC device was associated with significantly higher periprocedural complications (10.6%) compared to the Watchman device (2.7%), indicating a safety concern during the procedure.

However, in terms of long-term outcomes, both the Amulet and Watchman devices showed similar rates of complications, suggesting that their overall efficacy and safety profiles are comparable over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience. Saad, M., Risha, O., Sano, M., et al.[2022]

The CLAAS device, designed for left atrial appendage closure, was successfully implanted in 18 out of 22 patients with high stroke risk, demonstrating its clinical feasibility without serious procedural complications.

Follow-up at 45 days revealed only one significant leak and one device-related thrombus, both manageable, indicating that the CLAAS device is a safe option for patients with atrial fibrillation who require stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use. Sommer, RJ., Kim, JH., Szerlip, M., et al.[2022]

The Swiss-Apero study is the first randomized clinical trial comparing the Amulet and Watchman/FLX devices for left atrial appendage closure (LAAC), focusing on their leak rates after the procedure.

This trial will assess the superiority of the Amulet device over the Watchman/FLX in terms of post-procedural leaks detected by cardiac computed tomography angiography (CCTA) at 45 days and 13 months, providing important insights into the efficacy and safety of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. Galea, R., De Marco, F., Aminian, A., et al.[2022]

The Conformal Left Atrial Appendage Seal (CLAAS) device showed superior conformability in preclinical tests, effectively sealing various oval orifice sizes without gaps, unlike the Watchman 2.5 device.

In canine studies, the CLAAS implant achieved complete sealing of the left atrial appendage with no thrombus formation and demonstrated minimal inflammation after 60 days, indicating its potential safety and efficacy for stroke prevention in atrial fibrillation patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device. Sommer, RJ., Lamport, R., Melanson, D., et al.[2022]

The Amplatzer Amulet™ left atrial appendage occluder has recently been approved by the FDA as a new option for preventing embolic strokes in patients with nonvalvular atrial fibrillation, offering a dual seal mechanism that may enhance safety and efficacy compared to existing devices like the Watchman FLX.

This review provides comprehensive guidance on the entire process of using the Amulet device, including patient selection, imaging assessments, and implantation techniques, ensuring that healthcare providers can effectively utilize this new technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amplatzer Amulet™ left atrial appendage occluder: A step-by-step guide to device implantation. Ellis, CR.[2022]

Closure of the left atrial appendage (LAA) using devices like the WATCHMAN FLX™ Occluder can be a beneficial alternative for patients with non-valvular atrial fibrillation who cannot take anticoagulants due to bleeding risks.

This article provides a comprehensive overview of the indications, contraindications, and management of LAA closure procedures, highlighting the importance of careful patient selection and postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Left Atrial Appendage Closure - step by step]. Sievert, K., Bertog, S., Sievert, H.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Amplatzer Amulet™ left atrial appendage occluder: A step-by-step guide to device implantation. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Left Atrial Appendage Closure - step by step]. [2021]