UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059339 |
|---|---|
| Receipt number | R000067871 |
| Scientific Title | Feasibility and Efficacy of Intra-procedural Direct Current Cardioversion During Structural Heart Interventions in Patients With Atrial Fibrillation: A Prospective Study |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 15:04:00 |
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Basic information
Public title
Feasibility and Efficacy of Intra-procedural Direct Current Cardioversion During Structural Heart Interventions in Patients With Atrial Fibrillation: A Prospective Study
Acronym
INTRA-DC study
Scientific Title
Feasibility and Efficacy of Intra-procedural Direct Current Cardioversion During Structural Heart Interventions in Patients With Atrial Fibrillation: A Prospective Study
Scientific Title:Acronym
INTRA-DC study
Region
| Japan |
Condition
Condition
Atrial fibrillation, aortic stenosis, mitral regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility and efficacy of intra-procedural direct current cardioversion for atrial fibrillation during transcatheter aortic valve implantation or mitral transcatheter edge-to-edge repair
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of cardioversion
Key secondary outcomes
Rate of sinus rate at follow-up, echocardiographic findings, composite clinical endpoint based on VARC3 criteria (mortality, stroke, myocardial infarction, major bleeding, pacemaker implantation, acute kidney injury, device-related surgery or intervention)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Direct current cardioversion
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
| 20 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with atrial fibrillation deemed suitable for TAVI or M-TEER by a local heart team and undergoing the procedure under general anesthesia
Key exclusion criteria
Patients who have paroxysmal atrial fibrillation and present with sinus rhythm during the procedure
Patients who undergo TAVI or M-TEER under local anesthesia
Patients with intracardiac thrombus
Patients who are ineligible for direct current cardioversion for any reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Tanaka |
Organization
St. Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
TEL
044-977-8111
tetsu.tanaka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Tanaka |
Organization
St. Marianna Unversity School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
tetsu.tanaka@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Tetsu Tanaka
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
St. Marianna University School of Medicine
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
Tel
044-977-8111
tetsu.tanaka@marianna-u.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
| 2025 | Year | 10 | Month | 08 | 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
| 2025 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 11 | 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
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067871
