A non-randomized, multi-center study on the safety and efficacy of two monotherapiespost-left atrial appendage closure using the WATCHMAN FLX Pro device in patients with non-valvular atrial fibrillation(SAPT-LAA) (SAPT-LAA)
A study on two monotherapies after WATCHMAN FLX pro device closure in non-valvular atrial fibrillation (SAPT-LAA)
Kondo Yusuke
Chiba University Hospital
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
+81-43-222-7171
act.kondo@chiba-u.jp
Ryuzaki Satoko
Chiba University, Graduate School of Medicine
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
+81-43-222-7171
ryuzaki@chiba-u.jp
Recruiting
June. 19, 2024
July. 12, 2024
100
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
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
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) Systemic administration of steroids at a dose equivalent to or greater than 10mg/day of prednisone.
14) Presence of symptomatic carotid artery disease[defined as stenosis >50% on CTA, MRA, or TCD, accompanied by symptoms of transient monocularblindness, ipsilateral hemispheric transient ischemic attack, or ipsilateral stroke]. Eligible if post-carotid stent or endarterectomy with stenosis <50%.
15) Intracranial Atherosclerosis: Known intracranialatheromatous disease and/or small vessel disease (defined as a Fazekas Scale score of 6 points).
16) Not expected to survive for more than one year.
18age old over
No limit
Both
non-valvular atrial fibrillation
After percutaneous left atrial appendage closure, there are two groups. One is administered a reduceddose of anticoagulant for 3 months followed by aspirin for 3 months, and the other is administered antiplatelet agent(aspirin recommended) for 6 months.After 6 months, the physician may adjust the medication based on the patient's condition.
Percutaneous Left Atrial Appendage Closure, WATCHMAN FLX Pro, SAPT,DOAC
Percutaneous Left Atrial Appendage Closure, SAPT, Aspirin, Clopidogrel, Prasugrel
Composite events occurring within 6 months post-surgery:
All strokes*
All-cause mortality
Systemic embolism
ISTH major bleeding
*All strokes include ischemic stroke, hemorrhagic stroke, strokes with sequelae, and strokes without sequelae.
Composite events of ischemic stroke and systemic embolism occurring within 1 year post-surgery.
Effectiveness:
Discontinuation of DOAC and anticoagulants within45 days, 6 months, and 1 year post-procedure.
Composite events occurring within 45 days and 1 year post-surgery:
Device-related thrombosis based on CT or TEE evaluation
ISTH major bleeding
All strokes*
Systemic embolism
All-cause mortality
*All strokes include ischemic stroke, hemorrhagic stroke, strokes with sequelae, and strokes without sequelae.
Safety:
Composite events occurring within 45 days, 6 months, and 1 year post-surgery:
Surgery-related bleeding and non-surgery-related bleeding**
**: Bleeding is defined as major and minor bleedingaccording to ISTH bleeding criteria
Cardiovascular death
Non-cardiovascular death
Adverse events
Malfunctions (to determine if the event was causedby a malfunction)
Boston Scientific
Not applicable
Chiba University Graduate School of Medicine Department of Advanced Arrhythmia Bioengineering
Not applicable
Chiba University Certified Clinical Research Review Board
