CLAAS Device for Atrial Fibrillation

Recruiting at 84 trial locations

Overseen By Ken Malomo

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the CLAAS (Conformal Left Atrial Appendage Seal), for individuals with atrial fibrillation seeking an alternative to long-term blood thinners. The researchers aim to determine if the CLAAS device is as effective and safe as two existing devices, WATCHMAN and Amulet, which prevent strokes by closing off a part of the heart where clots tend to form. Participants will be randomly assigned to receive either the CLAAS or one of the existing devices and will be monitored for five years. The trial seeks individuals with a history of non-valvular atrial fibrillation and a high risk of stroke who are not ideal candidates for long-term blood thinner use. As an unphased trial, this study offers an opportunity to contribute to innovative research that could provide new options for stroke prevention.

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.

What prior data suggests that the CLAAS device is safe for patients with non-valvular atrial fibrillation?

Research has shown that the CLAAS device is generally well-tolerated. In a previous study, researchers successfully placed the device in 59 patients, with most experiencing no major problems before hospital discharge. Another report found that the device performed well over a year, with check-ups using special heart scans at 45 days and again at one year. These studies suggest that the CLAAS device is safe.

The FDA has already approved the WATCHMAN and Amulet devices for similar conditions. This approval indicates thorough testing and a proven safety record for many patients. These devices are often used to prevent strokes in people with atrial fibrillation, an irregular heartbeat. While side effects can occur, these devices maintain a strong safety record in the medical community. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CLAAS device because it offers a new approach to managing atrial fibrillation by sealing the left atrial appendage with a unique conformal fit. This transcatheter device differentiates itself from existing options like the WATCHMAN and Amulet devices, which also target the left atrial appendage but may not offer the same level of conformal sealing. The CLAAS device's novel design is aimed at reducing the risk of stroke in patients with atrial fibrillation more effectively, potentially improving patient outcomes and expanding the treatment options available.

What evidence suggests that the CLAAS device is effective for atrial fibrillation?

Research has shown that the CLAAS device, one of the treatments studied in this trial, holds promise for people with atrial fibrillation, a condition causing an irregular heartbeat. In one study, doctors implanted the CLAAS device in 59 patients. Follow-ups revealed it effectively sealed the heart's left atrial appendage, which is crucial because sealing this area reduces the risk of blood clots that can lead to strokes. Additionally, animal tests demonstrated that the device could seal effectively without causing harm over several months. These findings suggest that the CLAAS device could be a viable option for managing atrial fibrillation. The trial will also compare the CLAAS device to the WATCHMAN and Amulet devices, other options for left atrial appendage closure. ^{1 3 5 6 7}

Who Is on the Research Team?

William Gray, M.D.

Principal Investigator

Lankenau Heart Institute

Shephal Doshi, M.D.

Principal Investigator

Pacific Heart Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2021.08.060

Conformal Left Atrial Appendage Seal Device for ... - JACC Twenty-two patients (63.7% with CHA2DS2-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8213491/

Preclinical Assessment of a Novel Conformable Foam ... We present preclinical evaluations of a novel device, the Conformal Left Atrial Appendage Seal (CLAAS).

3. conformalmedical.com conformalmedical.com/company/news/conformal-medical-announces-compelling-one-year-data-from-its-left-atrial-appendage-occlusion-laao-early-feasibility-study

Conformal Medical Announces Compelling One-Year Data ... The CLAAS device was successfully implanted in 59 patients with transesophageal echo (TEE) performed intra-procedurally, at 45 days and again at ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03616028

NCT03616028 | The CONFORMAL Early Feasibility Study The Conformal Left Atrial Appendage Seal (CLAAS) Device is a permanent implant designed to occlude the left atrial appendage (LAA) to eliminate blood flow ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772930322005956

Foam-based Left Atrial Appendage Closure (CLAAS) Device The CLAAS implant can be deployed providing a good seal for up to 150 days without signs of local or systemic toxicity in a canine model.

6. innovationsincrm.com innovationsincrm.com/latest-news/2153-conformal-medical-announces-compelling-one-year-data

Conformal Medical Announces Compelling One-Year Data ... The CLAAS device was successfully implanted in 59 patients with transesophageal echo (TEE) performed intra-procedurally, at 45 days and again at one-year post- ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1936879821016691

Conformal Left Atrial Appendage Seal Device for ... Percutaneous LAAC devices have been shown to significantly reduce hemorrhagic strokes and to be noninferior to OAC for ischemic strokes (7, 8, 9 ...