ICE-Guided Watchman Device Implantation for Atrial Fibrillation

Overseen By Oussama Wazni, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Concomitant ablation, Prior incomplete ligation, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for placing the Watchman device, which helps prevent strokes in people with atrial fibrillation (an irregular heartbeat). Traditionally, doctors use Transesophageal Echocardiography (TEE), a special camera, but this study examines whether Intracardiac Echocardiography (ICE), a different type of camera, is equally effective. Suitable candidates for this trial have atrial fibrillation, qualify for a Watchman device, and are not participating in another clinical trial. As an unphased trial, this study allows patients to contribute to innovative research that could enhance stroke prevention methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for atrial fibrillation patients?

Research has shown that using Intracardiac Echocardiography (ICE) to guide the Watchman procedure is safe. Studies indicate that procedures using ICE have similar rates of major complications as the traditional method, which uses Transesophageal Echocardiography (TEE). Notably, ICE is linked to fewer stomach and digestive issues. One study with 27 patients found that ICE can safely and effectively assist in placing the Watchman device. Overall, this evidence suggests that ICE is a safe option for this procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intracardiac Echocardiography (ICE) for atrial fibrillation patients because it offers a novel approach to guiding the placement of the Watchman device. Unlike traditional methods that rely on transesophageal echocardiography (TEE), ICE is less invasive and can be performed without general anesthesia, making the procedure more comfortable for patients. Additionally, ICE allows for real-time imaging from within the heart, potentially improving the precision and safety of the Watchman device implantation. This could lead to better outcomes and fewer complications, which is why ICE is generating interest in the medical community.

What evidence suggests that ICE is effective for the Watchman procedure in atrial fibrillation?

Research has shown that using Intracardiac Echocardiography (ICE) to place the Watchman device, studied in this trial, is as effective as using Transesophageal Echocardiography (TEE). Studies have found no difference in the success of device implantation between the two methods. The Watchman device helps prevent strokes in people with atrial fibrillation, an irregular heartbeat. ICE reliably guides the device's placement, allowing doctors to see inside the heart without inserting a tube down the throat, which makes it more comfortable for patients. Overall, evidence supports ICE as a safe and effective option for this procedure. ^{6 7 8 9 10}

Who Is on the Research Team?

Oussama Wazni, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients who qualify for a Watchman heart device implant and aren't part of another clinical study. It's not for those getting an ablation procedure, with prior incomplete left atrial appendage closure, or issues that complicate trans-septal equipment delivery like PFO or ASD closures.

Inclusion Criteria

You are eligible for a Watchman device implant according to standard guidelines and are not currently in another research study.

Exclusion Criteria

You have a condition that would make it hard for the medical equipment to be delivered, such as having a PFO or ASD closure devices in place.

I am undergoing a procedure to destroy abnormal tissue.

I had an incomplete procedure to close off a part of my heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Intracardiac echocardiography (ICE) guided Watchman device implantation

During the procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intracardiac Echocardiography (ICE)

Trial Overview The study tests the effectiveness of using Intracardiac Echocardiography (ICE) instead of Transesophageal Echocardiography (TEE) to place the Watchman device in patients with conditions like Atrial Fibrillation.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Intracardiac Echocardiography (ICE)

Intracardiac Echocardiography (ICE) is already approved in European Union, United States for the following indications:

Approved in European Union as Watchman for:

• Reduction of the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation

Approved in United States as Watchman for:

• Reduction of the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study involving 2-day-old mice, the application of the ICE protease inhibitor YVAD-CHO to lesioned facial nerves resulted in a 32% reduction in apoptotic motoneurones, suggesting that ICE proteases play a role in nerve injury-induced cell death.

The findings indicate that targeting ICE or ICE-like proteases could be a potential strategy to delay motoneurone death following nerve injury, highlighting a possible therapeutic approach for nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute application of an interleukin-1 beta-converting enzyme-specific inhibitor delays axotomy-induced motoneurone death. de Bilbao, F., Dubois-Dauphin, M.[2019]

In a study of 27 patients with atrial fibrillation, transcatheter left atrial appendage closure using intracardiac echocardiography (ICE) guidance was found to be safe, with no major procedural complications reported.

The procedure was successful in all patients, with a 14.8% rate of minor complications, primarily access site hematomas, and confirmed effective closure of the left atrial appendage at 45 days post-implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Closure Under Intracardiac Echocardiographic Guidance: Feasibility and Comparison With Transesophageal Echocardiography. Matsuo, Y., Neuzil, P., Petru, J., et al.[2018]

The Watchman FLX device demonstrated a high procedural success rate of 93.4% in left atrial appendage occlusion (LAAO) among 91 patients, with technical success achieved in 99% of cases, indicating its efficacy for a wide range of LAA anatomies.

The use of intracardiac echocardiography (ICE) for guiding the implantation resulted in a low complication rate of 5.5%, with no device-related thrombosis reported, showcasing the safety of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Watchman FLX Device: First European Experience and Feasibility of Intracardiac Echocardiography to Guide Implantation. Korsholm, K., Samaras, A., Andersen, A., et al.[2021]

The study found that using intracardiac echocardiography (ICE) for 'one-stop' procedures combining radiofrequency catheter ablation and left atrial appendage closure (LAAC) resulted in significantly fewer cases of thrombus formation compared to transesophageal echocardiography (TEE), with only 1.46% in the ICE group versus 11.63% in the TEE group.

ICE-guided procedures also demonstrated advantages in terms of safety and efficiency, including less radiation exposure, shorter procedure times, and fewer postoperative complications compared to TEE, making ICE a preferable option for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intracardiac vs. transesophageal echocardiography for "one-stop" procedures of combined radiofrequency catheter ablation and left atrial appendage closure with the Watchman device in the treatment of atrial fibrillation. Shang, X., Sun, M., Wang, Z., et al.[2023]

The WATCHMAN™ LAA closure device is an effective mechanical strategy for preventing strokes in patients with atrial fibrillation (AF) by closing off the left atrial appendage, which is a major source of blood clots.

Clinical data from two randomized trials indicate that the safety of the WATCHMAN device has significantly improved over time, making it a viable alternative to traditional anticoagulants that carry bleeding risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion with the WATCHMAN™ for stroke prevention in atrial fibrillation. Price, MJ.[2022]

In a study of 58 patients undergoing WATCHMAN device implantation for atrial fibrillation, incomplete occlusion of the left atrial appendage (LAA) was observed in a significant number of cases, with gaps noted in 27.6% to 34.5% of patients over 12 months.

The study found that these gaps often persisted and could increase in size over time, raising concerns about the potential risk of thromboembolic events, as evidenced by two patients who experienced complications after discontinuing anticoagulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraprocedural and long-term incomplete occlusion of the left atrial appendage following placement of the WATCHMAN device: a single center experience. Bai, R., Horton, RP., DI Biase, L., et al.[2016]

Peptide inhibitors of the ICE protease family can prevent programmed cell death in motoneurons both in vitro and in vivo, suggesting a protective role against cell death due to trophic factor deprivation.

The study provides evidence that ICE or similar proteases are crucial in regulating not only motoneuron death but also the developmental cell death of interdigital cells, highlighting their importance in both neural and developmental processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide inhibitors of the ICE protease family arrest programmed cell death of motoneurons in vivo and in vitro. Milligan, CE., Prevette, D., Yaginuma, H., et al.[2019]

Transcatheter left atrial appendage (LAA) closure using devices like the Watchman has shown promising results in significantly reducing stroke risk in patients with atrial fibrillation, offering a potential alternative to traditional oral anticoagulants.

The Watchman device trials indicate that its efficacy in preventing strokes is comparable to that of warfarin, highlighting its effectiveness and supporting the concept of LAA closure as a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Closure with Transcatheter-Delivered Devices. Whisenant, B., Weiss, P.[2019]

The study highlights the role of the interleukin-1 beta converting enzyme (ICE) and its family members in neuronal death, suggesting that while ICE itself is not expressed in neurons, its homologs may mediate apoptosis and programmed cell death.

Given the involvement of ICE family members in neurodegenerative diseases, targeting these proteases with antagonists could offer neuroprotective benefits, potentially leading to new therapeutic strategies for conditions with apoptotic components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Watch for ICE in neurodegeneration. Vasilakos, J., Shivers, B.[2006]

Gamma-irradiation effectively induces apoptosis in human retinoblastoma cell lines (WERI-Rb-1 and Y79) in a dose-dependent manner, with a significant increase in the levels of interleukin-1beta-converting enzyme (ICE) observed after treatment.

Inhibition of ICE using a specific tetrapeptide inhibitor (Ac-YVAD-CMK) reduced gamma-irradiation-induced apoptosis, while overexpression of ICE alone was sufficient to trigger apoptosis, indicating its crucial role in the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involvement of interleukin-1beta-converting enzyme in apoptosis of irradiated retinoblastomas. Kondo, Y., Liu, J., Haqqi, T., et al.[2015]

The interleukin-1 beta converting enzyme (ICE) is involved in programmed cell death in vertebrates, similar to its role in the nematode C. elegans, suggesting a conserved mechanism across species.

Microinjecting the crmA gene from cowpox virus into chicken neurons can inhibit ICE activity and prevent cell death caused by nerve growth factor deprivation, highlighting a potential therapeutic approach to protect neurons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of vertebrate neuronal death by the crmA gene. Gagliardini, V., Fernandez, PA., Lee, RK., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7854490/

Left Atrial Appendage Occlusion Using Intracardiac ... Several studies have assessed the role of TEE versus ICE for LAAC 2–5 and found no differences in implant success rate between the two groups.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013750

Outcomes With the WATCHMAN FLX in Everyday Clinical ... The objective of the study was to evaluate the (1) safety and (2) outcomes through 1 year after implantation of the WATCHMAN FLX device in ...

3. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2022.10.024

The ICE LAA Study | JACC: Cardiovascular Interventions The ICE LAA (I Can See Left Atrial Appendage) study was a prospective, multicenter study with independent adjudication of echocardiographic data by a core ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X21008537

Intracardiac Echocardiography-Guided Left Atrial ... This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02508-1/fulltext

2025 SCAI/HRS clinical practice guidelines on ... Left atrial appendage occlusion (LAAO) devices reduce the risk of atrial fibrillation-associated stroke relative to no oral anticoagulation.

6. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.101570

Safety and Feasibility of 3D Intracardiac Echocardiography ... The novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00901-4/fulltext

PO-02-198 SAFETY AND FEASIBILITY OF ... - Heart Rhythm Concomitant PFA and LAAC with ICE-guidance is a feasible, safe, and efficient procedure in carefully selected patients.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772930322005415

Feasibility and Safety of Intracardiac Echocardiography ... ICE-guided LAAC is safer than TEE-guided LAAC, with similar rates of major complications. However, ICE use was associated with lower rates of gastrointestinal ...

9. ahajournals.org ahajournals.org/doi/10.1161/jaha.116.003695

Left Atrial Appendage Closure Under Intracardiac ... A total of 27 patients (11 males, 77.0±8.5 years) with atrial fibrillation receiving Watchman left atrial appendage closure under intracardiac ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X24008512

Safety and Feasibility of 3D Intracardiac Echocardiography ... The novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.