A study on single antiplatelet therapy after WATCHMAN FLX pro device closure in non-valvular atrial fibrillation

JRCT ID: jRCTs031240174

Registered date:19/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-valvular atrial fibrillation
• Date of first enrollment: 12/07/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): After percutaneous left atrial appendage closure, administer an oral antiplatelet drug once daily for six months.

Outcome(s)

Primary Outcome

Composite events of the following outcomes within 6 months post-surgery:
Major bleeding
Ischemic stroke
Hemorrhagic stroke
Stroke with sequelae
Stroke without sequelae
Systemic embolism
All-cause mortality

Secondary Outcome

Effectiveness:
Evaluation of stopping
anticoagulant
antiplatelet drugs
at 45 days, 6 months, and 1 year post-surgery.

Composite event of any of the following evaluation criteria occurring within 45 days, 6 months, or 1 year after the procedure:
Device-related thrombosis based on CT or TEE assessment.
Major bleeding.
Ischemic stroke.
Hemorrhagic stroke.
Stroke with sequelae.
Stroke without sequelae.
Systemic embolism.
All-cause mortality.

Safety:
Bleeding Related to the Procedure (Major and Minor) and Unrelated to the Procedure
Cardiovascular Death
Non-cardiovascular Death
Adverse Events
Device Malfunction(To assess whether the cause of the event is due to a malfunction in the combined medical device)
within 45 days, 6 months, and 1 year post-surgery.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with confirmed paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
2) Patients at high risk of stroke or systemic embolism (defined as a CHA2DS2 VASC score of 2 or more, 3 or more for women).
3) Patients who require long-term DOAC therapy.
4) Patients who can adhere to the prescribed regimen of a single antiplatelet drug.
5) Patients who have obtained written consent from themselves or their legal representatives to participate in the study.
6) Patients who are 18 years of age or older.
7) Patients who are able and willing to attend the clinic for the required follow-ups and evaluations.
8) Patients with a high risk of bleeding, including one of the following:
A HAS-BLED score of 3 or more.
Multiple past incidents requiring treatment due to trauma from falls.
History of cerebral amyloid angiopathy.
History of major bleeding corresponding to type 3 of the Bleeding Academic Research Consortium

Exclude criteria

1) Requires long-term anticoagulation for conditions other than AF.
2) Scheduled for cardiac interventions or surgeries requiring invasive procedures, sedation, or anesthesia within 3 months post-device implantation.
3) Known contraindications or allergies to aspirin, both clopidogrel and prasugrel, or DOACs.
4) History of atrial septal defect (ASD) repair or presence of an ASD closure device.
5) History of patent foramen ovale (PFO) repair or presence of a PFO closure device.
6) Presence of a mechanical artificial heart valve.
7) History of rheumatic or congenital mitral valve disease.
8) Underwent any cardiac or non-cardiac interventions or surgeries within 30 days prior to enrollment.
9) Underwent catheter ablation for AF or atrial flutter within 60 days prior to enrollment.
10) Congestive heart failure classified as NYHA functional class IV.
11) Left ventricular ejection fraction <=30% (based on the most recent evaluation).
12) Left atrial diameter >=55mm (based on the most recent evaluation).
13) History of systemic embolism under appropriate anticoagulant therapy.
14) Systemic administration of steroids at a dose equivalent to or greater than 10mg/day of prednisone.
15) Presence of symptomatic carotid artery disease [defined as stenosis >50% on CTA, MRA, or TCD, accompanied by symptoms of transient monocular blindness, ipsilateral hemispheric transient ischemic attack, or ipsilateral stroke]. Eligible if post-carotid stent or endarterectomy with stenosis <50%.
16) Intracranial Atherosclerosis: Known intracranial atheromatous disease and/or small vessel disease (defined as a Fazekas Scale score of 6 points).
17) Not expected to survive for more than one year.

Related Information

• Primary Sponsor: Kondo Yusuke
• Source(s) of Monetary Support: Chiba University Graduate School of Medicine Department of Advanced Arrhythmia Bioengineering