RecruitingNCT06686485

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Sponsor

Boston Scientific Corporation

Enrollment

433 participants

Start Date

Mar 18, 2025

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation Concomitant Procedures PFA LAAC

Summary

Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates combining two procedures in one session for patients with atrial fibrillation (an irregular heart rhythm): pulsed field ablation (a new way to correct abnormal electrical signals in the heart) and left atrial appendage closure (a procedure to reduce stroke risk by sealing off a small pouch in the heart). **You may be eligible if...** - Your doctor has recommended both ablation for atrial fibrillation and closure of the left atrial appendage - You are 18 years or older - You are willing and able to attend all required study visits **You may NOT be eligible if...** - You have had a prior ablation procedure for atrial fibrillation - Your atrial fibrillation is caused by a reversible condition (e.g., thyroid disease, alcohol) - You have a blood clot inside your heart - You had a stroke or mini-stroke (TIA) in the past 90 days - You had a heart attack in the past 30 days - You have a mechanical heart valve - You are pregnant or planning to be pregnant - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems

The FARAPULSE™ PFA System consists of the FARAWAVE™ Pulsed Field Ablation Catheter, the FARASTAR™ Pulsed Field Ablation Generator, and the FARADRIVE™ Steerable Sheath. The WATCHMAN LAA Closure Technology consists of the WATCHMAN Access System (which consists of the Access Sheath and Dilator and the WATCHMAN Delivery System (which consists of the delivery catheter and the pre-loaded closure device). The WATCHMAN Access System and WATCHMAN Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium.

Locations(30)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Beijing Anzhen Hospital of the Capital University of Medical Sciences

Beijing, China

Xuanwu Hospital Capital Medical University

Beijing, China

Huaxi Hospital of Sichuan University

Chengdu, China

Guangdong Nanfang Hospital

Guangzhou, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, China

QiLu Hospital of ShanDong University

Jinan, China

First People's Hospital of Yunnan Province

Kunming, China

Shanxi Cardiovascular Hospital

Taiyuan, China

Zigong First People's Hospital

Zigong, China

Prince of Wales Hospital

Hong Kong, Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Kowloon, Hong Kong

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kurashiki Central Hospital

Kurashiki-shi, Okayama Kurashiki-shi, Japan

Saitama Red Cross Hospital

Saitama, Saitama, Japan

Sakakibara Heart Institute, Sakakibara Heart Foundation

Fuchu-shi, Tokyo, Japan

Kokura Memorial Hospital

Fukuoka-ken, Japan

Yokosuka Kyosai Hospital

Kanagawa, Japan

Toho University Ohashi Medical Center

Meguro-ku, Japan

Osaka Keisatsu Hospital

Osaka, Japan

Institute Jantung Negara

Kuala Lumpur, Malaysia

Pusat Jantung Sarawak

Kuching, Malaysia

Asian Heart and Vascular Centre

Singapore, Singapore

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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