ICE-Guided Watchman Device Implantation for Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Disqualifiers: Concomitant ablation, Prior incomplete ligation, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12356How 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.
7891011Eligibility Criteria
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.
+1 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
References
The Watchman FLX Device: First European Experience and Feasibility of Intracardiac Echocardiography to Guide Implantation. [2021]The aim of this study was to investigate the procedural efficacy and safety of the novel Watchman FLX (Boston Scientific, Marlborough, Massachusetts) device for left atrial appendage occlusion (LAAO) and to assess the feasibility of intracardiac echocardiography (ICE) to guide implantation.
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]This study aimed to assess the efficacy and safety of "one-stop" procedures that combined radiofrequency catheter ablation and left atrial appendage closure (LAAC) with the Watchman device under the guidance of intracardiac echocardiography (ICE) vs. transesophageal echocardiography (TEE) in patients with atrial fibrillation.
Left atrial appendage occlusion with the WATCHMAN™ for stroke prevention in atrial fibrillation. [2022]Atrial fibrillation (AF) is a major cause of stroke and systemic embolism. Although warfarin and the novel oral anticoagulants reduce thromboembolic risk, they are associated with an ongoing bleeding hazard, in addition to other limitations that deter their use. The left atrial appendage (LAA) appears to be the primary source of thrombus in AF; therefore, LAA closure represents a mechanical strategy for stroke prevention in these patients. The WATCHMAN™ LAA closure device (Boston Scientific, Natick, MA) is a nitinol-framed occluder that is implanted percutaneously under echocardiographic and fluoroscopic guidance. Data from two randomized clinical trials support the clinical efficacy of transcatheter LAA occlusion with the WATCHMAN and demonstrate that procedural safety has improved significantly since initial experience. This article summarizes the rationale, procedural technique, safety, and clinical efficacy of the WATCHMAN device in patients with AF at high risk for thromboembolic events.
Intraprocedural and long-term incomplete occlusion of the left atrial appendage following placement of the WATCHMAN device: a single center experience. [2016]Transcatheter left atrial appendage (LAA) closure with the WATCHMAN device has become one of the therapeutic options in atrial fibrillation (AF) patients who are at high risk for ischemic stroke. However, the incidence and evolution of incomplete occlusion of the LAA during and after placement of the WATCHMAN device has not been reported.
Left Atrial Appendage Closure Under Intracardiac Echocardiographic Guidance: Feasibility and Comparison With Transesophageal Echocardiography. [2018]Transcatheter left atrial appendage closure is an alternative therapy for stroke prevention in atrial fibrillation patients. These procedures are currently guided with transesophageal echocardiography and fluoroscopy in most centers. As intracardiac echocardiography (ICE) is commonly used in other catheter-based procedures, we sought to determine the safety and effectiveness of intracardiac echocardiography-guided left atrial appendage closure with the Watchman device.
Left Atrial Appendage Closure with Transcatheter-Delivered Devices. [2019]Left atrial appendage (LAA) closure with transcatheter-delivered devices is an evolving story of compelling randomized data and the potential to dramatically reduce the incidence of stroke and improve the quality of life among patients with atrial fibrillation. Oral anticoagulation is the standard of care for stroke prevention in atrial fibrillation but falls short of providing an adequate solution to this common threat when considered from efficacy and safety perspectives. The robust series of Watchman device trials has demonstrated the Watchman device to provide stroke prevention efficacy similar to that of warfarin and by extension provides proof of concept of LAA closure.
Acute application of an interleukin-1 beta-converting enzyme-specific inhibitor delays axotomy-induced motoneurone death. [2019]When performed during the postnatal period, lesioning of the facial nerve induces apoptotic death of facial motoneurones. Several lines of evidence indicate that the ICE proteases family, the mammalian homologues of Ced-3, are positive effectors of this process. In order to determine whether these proteases are involved in axotomy-induced cell death in vivo, we applied a peptide inhibitor of ICE, YVAD-CHO, to the lesioned facial nerve of 2-day-old mice. The effect of YVAD-CHO on motoneurone death was tested using the terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end-labelling (TUNEL) method, which labels apoptotic DNA breaks in situ. Our results show that acute application of YVAD-CHO can partially delay motoneurone death since 32% fewer TUNEL-labelled motoneurones were observed in treated mice. These results indicate that ICE or ICE-like proteases may be involved in the cell death processes induced by an axotomy in vivo.
Watch for ICE in neurodegeneration. [2006]Neuronal death occurs naturally during brain development and is a common response to an external insult. Cell death, whose mechanisms are currently being elucidated, appears in three forms: necrosis, apoptosis and programmed cell death. Recently, attention has focused on a family of cysteine proteases whose prototype is interleukin-1 beta converting enzyme (ICE). ICE, essential for IL-1 beta production and, thus, critical to necrotic mechanisms, also plays a role in apoptosis mediated through the stimulation of the lymphocyte fas antigen. The absence of ICE expression in neurons makes ICE an unlikely direct participant in neuronal death. However, the existence of ICE family members in neurons combined with the pharmacological inhibition of both apoptosis in vitro and programmed cell death during development make ICE homologs candidates for mediating these two forms of cell death. Since several neurodegenerative diseases as well as at least one neurological disorder may have an apoptotic component, antagonists of this protease family may be neuroprotective.
Involvement of interleukin-1beta-converting enzyme in apoptosis of irradiated retinoblastomas. [2015]To investigate whether interleukin-1beta-converting enzyme (ICE), a mammalian homologue of the Caenorhabditis elegans cell death gene ced-3, is involved in gamma-irradiation-induced apoptosis (programmed cell death) of human retinoblastoma cells.
Peptide inhibitors of the ICE protease family arrest programmed cell death of motoneurons in vivo and in vitro. [2019]Members of the CED-3/interleukin-1 beta-converting enzyme (ICE) protease family have been implicated in cell death in both invertebrates and vertebrates. In this report, we show that peptide inhibitors of ICE arrest the programmed cell death of motoneurons in vitro as a result of trophic factor deprivation and in vivo during the period of naturally occurring cell death. In addition, interdigital cells that die during development are also rescued in animals treated with ICE inhibitors. Taken together, these results provide the first evidence that ICE or an ICE-like protease plays a regulatory role not only in vertebrate motoneuron death but also in the developmentally regulated deaths of other cells in vivo.
Prevention of vertebrate neuronal death by the crmA gene. [2019]Interleukin-1 beta converting enzyme (ICE) is a mammalian homolog of CED-3, a protein required for programmed cell death in the nematode Caenorhabditis elegans. The activity of ICE can be specifically inhibited by the product of crmA, a cytokine response modifier gene encoded by cowpox virus. Microinjection of the crmA gene into chicken dorsal root ganglion neurons was found to prevent cell death induced by deprivation of nerve growth factor. Thus, ICE is likely to participate in neuronal death in vertebrates.