UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062898 |
|---|---|
| Receipt number | R000071973 |
| Scientific Title | Thoracoscopic Epicardial Left Atrial Appendage Occlusion Strategy for Anticoagulation-Free Management in Atrial Fibrillation: A Multicenter Pilot Randomized Controlled Trial of Anticoagulation Discontinuation |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/11 16:59:18 |
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Basic information
Public title
A Study of Anticoagulation Discontinuation After Stand-Alone Thoracoscopic Left Atrial Appendage Occlusion
Acronym
TELOS-AF trial
Scientific Title
Thoracoscopic Epicardial Left Atrial Appendage Occlusion Strategy for Anticoagulation-Free Management in Atrial Fibrillation: A Multicenter Pilot Randomized Controlled Trial of Anticoagulation Discontinuation
Scientific Title:Acronym
TELOS-AF trial
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the safety and efficacy of anticoagulation discontinuation after stand-alone thoracoscopic left atrial appendage occlusion in patients with non-valvular atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of the composite primary endpoint of stroke (ischemic stroke or intracerebral hemorrhage) or systemic embolism during the 1-year period after randomization.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anticoagulation therapy will be continued for 3 months after stand-alone thoracoscopic left atrial appendage occlusion and discontinued after confirmation of complete left atrial appendage closure at 3 months.
Interventions/Control_2
Anticoagulation therapy will be continued beyond 3 months after stand-alone thoracoscopic left atrial appendage occlusion.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with non-valvular atrial fibrillation who are scheduled to undergo elective stand-alone thoracoscopic left atrial appendage occlusion.
2. Patients aged 18 years or older.
3. Patients with a CHA2DS2-VASc score of >=2 (>=3 for women).
Key exclusion criteria
1. Patients with a left ventricular ejection fraction (LVEF) <25%.
2. Patients who are unable to tolerate single-lung ventilation.
3. Patients in whom thoracoscopic surgery via the left thoracic cavity is considered difficult because of anticipated severe left pleural adhesions (e.g., previous left lung surgery).
4. Patients with hypertrophic cardiomyopathy or a history of left atrial thrombus outside the left atrial appendage.
5. Patients who are considered to require long-term anticoagulation for other indications, regardless of left atrial appendage closure.
6. Patients who are unable to undergo ECG-gated contrast-enhanced CT because of renal dysfunction or other reasons.
7. Patients considered unsuitable for participation in this study by the principal investigator or study investigators.
8. Patients who are currently participating or plan to participate in another clinical trial or interventional study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshikatsu |
| Middle name | |
| Last name | Saiki |
Organization
Tohoku University Graduate School of Medicine
Division name
Cardiovascular Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Sendai, Miyagi, Japan
TEL
022-717-7222
yoshikatsu.saiki.e4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Hosoyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Cardiovascular Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Sendai, Miyagi, Japan
TEL
022-717-7222
Homepage URL
katsuhiro.hosoyama.a1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Sendai, Miyagi, Japan
Tel
022-728-4105
ec-med@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 12 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071973
