Watchman ICE

JRCT ID: jRCTs052220202

Registered date:27/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-valvular atrial fibrillation
• Date of first enrollment: 10/08/2023
• Target sample size: 42
• Study type: Interventional

Intervention(s)

Implantation of the WATCHMAN FLX Left Ear Closure System is usually performed by X-ray fluoroscopy and transesophageal echocardiography (TEE).Patients who met the selection criteria for this study and did not meet the exclusion criteria
Fluoroscopic radiography and transcardiac echocardiography (ICE) to determine the implantation site

Outcome(s)

• Primary Outcome: Percentage of residual blood flow greater than 5 mm based on TEE evaluation at 45 days after implantation

Secondary Outcome

Incidence of ischemic or hemorrhagic stroke up to 45 days after implantation
Incidence of systemic embolism up to 45 days after implantation
Incidence of BARC 3-5 hemorrhage up to 45 days after implantation
Incidence of all-cause mortality up to 45 days after implantation
Pericardiocentesis or pericardial effusion/pericardial effusion requiring surgical treatment up to 45 days after implantation
Incidence of pericardial effusion/pericardial tamponade requiring pericardiocentesis or surgical treatment up to 45 days after implantation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Subjects who are eligible for WATCHMAN FLX (indications must be in accordance with the Japanese package insert and the guidelines for appropriate use by the Japanese Society of Cardiology) *See Appendix for guidelines for use.
2.subjects 20 years of age or older who are eligible to participate in the study
3.subjects with documented paroxysmal, persistent, permanent, or long-standing non-valvular atrial fibrillation
4.subjects who are judged by the treating physician to be eligible for the drug treatment regimen specified in the study protocol
5.eligible for ICE (at the time of WATCHMAN FLX implantation) and TEE (preoperative screening, WATCHMAN FLX implantation, and 45-day follow-up)
6.subjects who are able to understand the written consent document and give written consent to participate in the study
7.subjects who are able and willing to make the necessary follow-up visits and examinations

Exclude criteria

1.Patients with intracardiac (especially intra-atrial) thrombus
2.patients with a history of repair of atrial septal defects or patent foramen ovale (surgical procedure, device implantation, etc.) or suture closure of the atrial septum
3.Patients whose left auricle anatomy is not compatible with a closure device.
4.patients with contraindications to left ear closure (e.g., difficulty inserting a transesophageal echocardiographic probe or catheter necessary for the procedure)
5.patients with contraindications to anticoagulation, aspirin or thienopyridines
6.patients enrolled in other interventional clinical trials
7.patients who require long-term anticoagulation for purposes other than reducing the risk of stroke due to AF, e.g., because of an underlying hypercoagulable condition (patients who may not be able to discontinue OAC (oral anticoagulants) due to other medical conditions requiring anticoagulation even if the device is implanted)
8.patients with implanted mechanical valves, regardless of site
9.patients with New York Heart Association Classification of Cardiac Function Classification 4 congestive heart failure
10.patients who are pregnant or lactating at the time of consent (testing procedures are at the discretion of the study investigator)
11.patients with sepsis
12.patients with severe peripheral vascular disease or abnormalities
13.patients with deep vein thrombosis
14.Patients with LVEF <30% within 90 days before surgery
15.patients with intracardiac thrombus confirmed by baseline imaging (performed within 90 days before surgery)
16.patients with pericardial effusions with a surrounding echo free space greater than 5 mm, signs or symptoms of acute or chronic pericarditis, or physiologic findings (clinical or echocardiographic) of cardiac tamponade
17.patients with an atrial septal mass greater than 15 mm in amplitude or distance and at high risk for patent foramen ovale (PFO)
18.patients with significant mitral stenosis (mitral valve less than 1.5 cm2)
19. patients with cardiac tumor
20.Patients who are deemed by the investigator or subinvestigator to be ineligible to participate in this study for any other reason

Related Information

• Primary Sponsor: Kusano Kengo
• Source(s) of Monetary Support: Boston Scientific KK