UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061221 |
|---|---|
| Receipt number | R000069993 |
| Scientific Title | Tandem approach |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/10 06:42:28 |
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Basic information
Public title
Upfront tandem versus superior-first approach for transvenous lead extraction: a Japanese single-center experience
Acronym
Tandem approach for TLE
Scientific Title
Tandem approach
Scientific Title:Acronym
Tandem approach
Region
| Japan |
Condition
Condition
Consecutive patients who underwent TLE between September 2014 and March 2026.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By focusing on the timing of femoral access, this study aimed to determine whether an upfront tandem approach can achieve comparable procedural success with similar safety and to inform extraction strategies for complex cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete procedural success , clinical procedural success, cardiac or vascular injury, and procedure-related death
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive patients who underwent TLE between September 2014 and March 2026.
Key exclusion criteria
The patients were excluded if they underwent planned hybrid TLE requiring thoracotomy.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | ISAWSA |
Organization
Sendai Kousei Hospital
Division name
Cardiology Department
Zip code
981-0914
Address
1-20, Tsutsumidouri-amamiya, Sendai, Japan
TEL
0227288000
isa_tsuyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | ISAWA |
Organization
Sendai Kousei Hospital
Division name
Cardiology Department
Zip code
981-0914
Address
1-20, Tsutsumidouri-amamiya, Sendai, Japan
TEL
022-728-8000
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Sendai Kousei Hospital
Address
1-20, Tsutsumidouri-amamiya,Sendai
Tel
0227288000
isa_tsuyo@yahoo.co.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 | 04 | Month | 10 | 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
320
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We identified all consecutive patients who underwent TLE between September 2014 and March 2026. Patients were classified into two groups according to the timing of femoral snare use: (1) the upfront tandem approach group, in which femoral access was established at the outset of the procedure, and (2) the superior-first approach group, in which femoral access was introduced only after failure of the superior route.
Management information
Registered date
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069993
