UMIN-ICDS Clinical Trial

Public title

A Study of Thoracoscopic Left Atrial Appendage Occlusion to Discontinue Oral Anticoagulation After Atrial Fibrillation Ablation

Acronym

Thoracoscopic LAAO After AF Ablation Trial

Scientific Title

Thoracoscopic LAAO After AF Ablation Trial

Scientific Title:Acronym

Japan

Region

Japan

Condition

Nonvalvular atrial fibrillation with maintenance of sinus rhythm after catheter ablation

Classification by specialty

Cardiology

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To exploratorily evaluate the efficacy, safety, and feasibility of a strategy of thoracoscopic left atrial appendage occlusion followed by oral anticoagulation discontinuation compared with continued oral anticoagulation in high-risk patients with no clinically documented recurrence of AF, AFL, or AT for at least 12 months after catheter ablation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

A composite endpoint of ischemic stroke, systemic embolism, ISTH major bleeding, and cardiovascular death occurring within 12 months after randomization, assessed using a time-to-first-event analysis.

Key secondary outcomes

Clinical outcomes: ischemic stroke, systemic embolism, ISTH major bleeding, clinically relevant non-major bleeding (CRNMB), cardiovascular death, and all-cause death through 12 months after randomization.
Procedure-related outcomes: proportion of patients undergoing the assigned LAAO procedure, major procedure-related complications within 30 days after surgery, procedural success, and complete LAA closure.
Anticoagulation-related outcomes: completion rate of eligibility assessment for OAC discontinuation at 3 months after surgery, achievement of the OAC discontinuation strategy at 6 months after randomization, OAC discontinuation rate at 6 months among patients who underwent LAAO, OAC resumption rate through 12 months, and time to OAC discontinuation.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine	Device,equipment	Maneuver

Interventions/Control_1

Oral anticoagulation (OAC) continuation group. OAC with a direct oral anticoagulant (DOAC) or warfarin is continued according to current guidelines and standard clinical practice. The choice and dose of OAC and any dose adjustments are determined by the treating physician based on renal function, age, body weight, concomitant medications, bleeding risk, and other clinical factors. The primary assessment period is 12 months after randomization, and all participants are followed for 24 months. After completion of the 12-month primary assessment, crossover to thoracoscopic left atrial appendage occlusion is permitted for patients who request it after reassessment of eligibility.

Interventions/Control_2

OAC discontinuation strategy using thoracoscopic left atrial appendage occlusion. In principle, isolated thoracoscopic left atrial appendage occlusion using AtriClip is performed within 30 days after randomization under general anesthesia with single-lung ventilation. Concomitant surgical ablation, including Maze procedures or pulmonary vein isolation, is not permitted. After surgery, OAC is resumed after adequate hemostasis and continued for at least 45 days and until assessment for OAC discontinuation has been completed by imaging performed 45-90 days after surgery. Complete LAA closure is assessed by ECG-gated contrast-enhanced cardiac CT, or by transesophageal echocardiography when CT is not feasible. OAC may be discontinued at the treating physician's discretion when complete closure is confirmed and there is no left atrial or residual LAA thrombus, recurrence of AF/AFL/AT, or other indication for continued OAC. OAC is continued if incomplete closure, thrombus, atrial arrhythmia recurrence, or another indication for anticoagulation is present. All participants are followed for 24 months after randomization.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients must meet all of the following criteria:

1.Age >=18 years at the time of informed consent.
2.History of catheter ablation for nonvalvular atrial fibrillation.
3.At least 12 months have elapsed since the last catheter ablation.
4.No AF, AFL, or AT lasting >=30 seconds has been documented during the 12 months before enrollment by available 12-lead ECG, portable ECG, Holter monitoring, implanted cardiac devices, or other rhythm recordings, and sinus rhythm has been confirmed on at least two occasions, including at least one assessment within 30 days before enrollment.
5.CHADS2 score >=2 at enrollment.
6.HAS-BLED score >=2 at enrollment.
7.An indication for continued OAC according to current clinical guidelines and the treating cardiologist, with OAC being taken at enrollment.
8.Considered by both a cardiologist and cardiovascular surgeon to be medically eligible for either continued OAC or an OAC discontinuation strategy using thoracoscopic LAAO.
9.Able to provide written informed consent voluntarily.

Key exclusion criteria

Patients will be excluded if any of the following apply:

1.Mechanical prosthetic valve or moderate/severe rheumatic mitral stenosis.
2.Need for long-term OAC for a reason other than AF.
3.LA/LAA thrombus on TEE or ECG-gated contrast CT within 60 days before enrollment.
4.Ischemic stroke, systemic embolism, or ISTH major bleeding within 6 months.
5.Active significant bleeding, absolute OAC contraindication, or inability to continue OAC until postoperative imaging.
6.LVEF <40% within 6 months.
7.Hypertrophic cardiomyopathy, cardiac amyloidosis, or other cardiomyopathy substantially affecting prognosis/thromboembolic risk.
8.Life expectancy <24 months due to malignancy, end-stage organ disease, or other serious illness.
9.Embolic source other than the LAA (e.g., LV thrombus or mobile aortic atheroma).
10.Inability to tolerate general anesthesia, single-lung ventilation, or left thoracoscopic surgery.
11.Prior left thoracotomy, left lung resection, pleurodesis, empyema, or anticipated severe left pleural adhesions.
12.Pregnancy, breastfeeding, or possible pregnancy.
13.Inability to undergo either ECG-gated contrast CT or TEE 45-90 days after surgery.
14.Expected need for DAPT >3 months, or OAC plus DAPT, within 12 months.
15.Planned cardiac/thoracic surgery or percutaneous/surgical LAA closure within 12 months.
16.Participation in another interventional study/trial that may affect safety or endpoints.
17.Inability to complete scheduled visits/tests or 24-month follow-up.
18.Inability to undergo intraoperative TEE.
19.Any other condition considered inappropriate by the investigator.

Target sample size

200

Name of lead principal investigator

1st name	Taisuke
Middle name
Last name	Nakayama

Organization

Medical Corporation Tokushukai Chibanishi General Hospital

Division name

Department of Cardiovascular Surgery

Zip code

270-2251

Address

107-1 Kanegasaku, Matsudo City, Chiba 270-2251, Japan

TEL

047-384-8111

Email

taisuke.nakayama0129@gmail.com

Name of contact person

1st name	Taisuke
Middle name
Last name	Nakayama

Organization

Medical Corporation Tokushukai Chibanishi General Hospital

Division name

Department of Cardiovascular Surgery

Zip code

270-2251

Address

107-1 Kanegasaku, Matsudo City, Chiba 270-2251, Japan

TEL

047-384-8111

Homepage URL

Email

taisuke.nakayama0129@gmail.com

Institute

Medical Corporation Tokushukai Chibanishi General Hospital

Institute

Department

Personal name

Taisuke Nakayama

Organization

AtriCure, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

United States of America

Co-sponsor

Name of secondary funder(s)

Organization

The Tokushukai Group Ethics Committee

Address

Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan

Tel

03-3263-4801

Email

mirai-ec1@mirai-iryo.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

千葉西総合病院（千葉県）
愛媛大学医学部附属病院（愛媛県）
東北大学病院（宮城県）
山口県済生会下関総合病院（山口県）
淀川キリスト教病院（大阪府）
広島大学病院（広島県）
札幌ハートセンター（北海道）
松本協立病院（長野県）
広島ハートセンター（広島県）
上尾中央総合病院（埼玉県）
名古屋ハートセンター（愛知県）
岐阜ハートセンター（岐阜県）
足利赤十字病院（栃木県）
札幌孝仁会記念病院（北海道）
中部徳洲会病院（沖縄県）
京都第二赤十字病院（京都府）
友愛医療センター（沖縄県）
福山市民病院（広島県）
聖隷三方原病院（静岡県）
徳島大学病院（徳島県）
沖縄県立中部病院（沖縄県）
榊原記念病院（東京都）
熊本中央病院（熊本県）
山口県済生会山口総合病院（山口県）
浜松医科大学医学部附属病院（静岡県）
佐世保中央病院（長崎県）
徳山中央病院（山口県）
埼玉東部循環器病院（埼玉県）

Date of disclosure of the study information

2026

Year

09

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

0

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

No plan to share individual participant data.

IPD sharing Plan description

There is currently no plan to share individual participant data with external researchers. If the data are used for future research related to this study, a new research protocol will undergo ethics review and approval by the relevant institution before such use.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

20

Day

Date of IRB

Anticipated trial start date

2027

Year

01

Month

01

Day

Last follow-up date

2030

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Not applicable

Registered date

2026

Year

09

Month

20

Day

Last modified on

2026

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072127