100 Participants Needed

ICE-Guided Watchman Device Implantation for Atrial Fibrillation

SN
Overseen ByShady Nakhla, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.

Will I have to stop taking my current medications?

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

Is the ICE-guided Watchman device implantation safe for humans?

The Watchman device, used for closing the left atrial appendage to prevent strokes in atrial fibrillation patients, has been shown to be safe in humans, with procedural safety improving significantly over time. Intracardiac echocardiography (ICE) is a feasible method to guide the implantation of the Watchman device, and studies have demonstrated its safety in these procedures.12345

How is the ICE-Guided Watchman Device Implantation treatment for atrial fibrillation different from other treatments?

The ICE-Guided Watchman Device Implantation is unique because it uses intracardiac echocardiography (ICE) to guide the placement of a device that closes the left atrial appendage, reducing the risk of stroke in patients with atrial fibrillation. This approach is different from traditional treatments like blood thinners, as it physically prevents blood clots from forming in the heart.678910

What data supports the effectiveness of the treatment ICE-Guided Watchman Device Implantation for Atrial Fibrillation?

Research shows that using the Watchman device for closing the left atrial appendage (a small pouch in the heart) can help prevent strokes in people with atrial fibrillation (a heart rhythm disorder). Studies have found that using intracardiac echocardiography (a type of heart imaging) to guide the implantation of the Watchman device is both safe and effective.123411

Who Is on the Research Team?

SN

Shady Nakhla, 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.
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention

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

🇪🇺
Approved in European Union as Watchman for:
🇺🇸
Approved in United States as Watchman for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Published Research Related to This Trial

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

Citations

The Watchman FLX Device: First European Experience and Feasibility of Intracardiac Echocardiography to Guide Implantation. [2021]
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. [2023]
Left atrial appendage occlusion with the WATCHMAN™ for stroke prevention in atrial fibrillation. [2022]
Intraprocedural and long-term incomplete occlusion of the left atrial appendage following placement of the WATCHMAN device: a single center experience. [2016]
Left Atrial Appendage Closure Under Intracardiac Echocardiographic Guidance: Feasibility and Comparison With Transesophageal Echocardiography. [2018]
Left Atrial Appendage Closure with Transcatheter-Delivered Devices. [2019]
Acute application of an interleukin-1 beta-converting enzyme-specific inhibitor delays axotomy-induced motoneurone death. [2019]
Watch for ICE in neurodegeneration. [2006]
Involvement of interleukin-1beta-converting enzyme in apoptosis of irradiated retinoblastomas. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Peptide inhibitors of the ICE protease family arrest programmed cell death of motoneurons in vivo and in vitro. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Prevention of vertebrate neuronal death by the crmA gene. [2019]
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