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Double whammy for AFib: single procedure aims to fix rhythm and prevent strokes

NCT ID NCT06686485

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This study tests doing two heart procedures at the same time for people with atrial fibrillation. First, doctors use pulsed field energy to fix the heart's rhythm. Then, they implant a small device to close off a part of the heart where clots can form. The goal is to see if this combined approach is safe and works well. About 433 adults who need both treatments will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FARAPULSE PFA system and WATCHMAN LAAC device
What this could lead to
If successful, this could show that combining two procedures in one session is safe and effective, simplifying treatment for atrial fibrillation patients.
What could go wrong
This is a mid-stage trial, so results may not confirm long-term benefits. There are risks from both the ablation and device implantation, including serious adverse events.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 433 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects enrolled in the OPTION-A study will be clinically indicated for an Atrial Fibrillation ablation procedure utilizing the FARAPULSE PFA System as well as implantation of the WATCHMAN device per physician's medical judgement, and according to the hospitals' standard of care during the same procedure. The subjects selected for participation in the study will be from the investigator's general patient population. The investigator or designee has the responsibility for screening all potential subjects and selecting those who meet study eligibility criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care. 2. Subjects who are willing and able to provide informed consent. 3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center. 4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Subjects who underwent prior AF ablation procedure. 2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes. 3. Already surgically closed or otherwise excluded LAA. 4. The LAA anatomy does not accommodate a Closure Device. 5. Known or suspected atrial myxoma. 6. Presence of intracardiac thrombus. 7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device. 8. Subjects with a presence of a mechanical valve prosthesis in any position. 9. Subjects with a myocardial infarction within 30 days prior to enrollment. 10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment. 11. Any planned electrical cardioversion within 30 days following LAAC device implant. 12. Subjects with a known inability to obtain vascular access. 13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\*. 14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present. 15. Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation. 16. Subjects who are pregnant or planning to be pregnant. 17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion. 18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation PFAPA syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Concomitant procedures LAAC PFA

Contacts and locations

Locations

  • Affiliated Hospital of Nantong University

    Nantong, China

  • Asian Heart and Vascular Centre

    Singapore, Singapore

  • Beijing Anzhen Hospital of the Capital University of Medical Sciences

    Beijing, China

  • China Medical University Hospital

    Taichung, Taiwan

  • First People's Hospital of Yunnan Province

    Kunming, China

  • Guangdong Nanfang Hospital

    Guangzhou, China

  • Huaxi Hospital of Sichuan University

    Chengdu, China

  • Institute Jantung Negara

    Kuala Lumpur, Malaysia

  • Kawasaki Saiwai Hospital

    Kawasaki, Japan

  • Kokura Memorial Hospital

    Fukuoka-ken, Japan

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama Kurashiki-shi, Japan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Osaka Keisatsu Hospital

    Osaka, Japan

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

  • Princess Margaret Hospital

    Hong Kong, Hong Kong

  • Pusat Jantung Sarawak

    Kuching, Malaysia

  • QiLu Hospital of ShanDong University

    Jinan, China

  • Queen Elizabeth Hospital

    Kowloon, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Saitama Red Cross Hospital

    Saitama, Saitama, Japan

  • Sakakibara Heart Institute, Sakakibara Heart Foundation

    Fuchu-shi, Tokyo, Japan

  • Sendai Kousei Hospital

    Sendai, Miyagi, Japan

  • Shanxi Cardiovascular Hospital

    Taiyuan, China

  • Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa, Japan

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, China

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, China

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, China

  • Toho University Ohashi Medical Center

    Meguro-ku, Japan

  • Xuanwu Hospital Capital Medical University

    Beijing, China

  • Yokohama city minato Red Cross Hospital

    Yokohama, Japan

  • Yokosuka Kyosai Hospital

    Kanagawa, Japan

  • Zhuhai People's Hospital

    Zhuhai, China

  • Zigong First People's Hospital

    Zigong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.