UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055854 |
|---|---|
| Receipt number | R000063835 |
| Scientific Title | Arrhythmogenic Mechanisms of the Vein of Marshall in the Onset and Maintenance of Atrial Fibrillation |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/10/16 18:05:58 |
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Basic information
Public title
Mechanisms Linking the Vein of Marshall to the Onset and Maintenance of Atrial Fibrillation
Acronym
The Relationship Between Atrial Fibrillation and the Vein of Marshall
Scientific Title
Arrhythmogenic Mechanisms of the Vein of Marshall in the Onset and Maintenance of Atrial Fibrillation
Scientific Title:Acronym
The Arrhythmogenic Role of the Vein of Marshall in Atrial Fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the arrhythmogenic mechanisms of the vein of Marshall through electrophysiological and biochemical examinations, while also evaluating the impact of its arrhythmogenicity on the recurrence of arrhythmias after catheter ablation for atrial fibrillation. Ultimately, the goal is to contribute to improving the prognosis of patients with atrial fibrillation.
Basic objectives2
Others
Basic objectives -Others
An electrode catheter will be inserted into the vein of Marshall to perform electrophysiological study. Furthermore, blood samples will be obtained from the vein of Marshall.In the electrophysiological study, pacing from the vein of Marshall will be used to assess the extent of electrical coupling between the vein of Marshall and the left atrium, the occurrence of reentry, and the induction of atrial fibrillation. Biochemical markers will also be measured in the blood samples. The data obtained from these testing will be evaluated for their correlation with arrhythmia recurrence after ablation observed during follow-up.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure is the correlation between the recurrence of atrial fibrillation or atrial tachycardia after ablation and the electrophysiological findings of the vein of Marshall.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Induction and Evaluation of Marshall Vein-Left Atrium Reentry
A 1.6Fr electrode catheter will be inserted into the vein of Marshall. Premature stimulation and burst stimulation will be delivered from the electrode catheter. Local potentials of the vein of Marshall will be observed during each stimulation to evaluate the presence of Marshall vein-left atrium reentry. The induction of atrial arrhythmias will also be assessed. Pulmonary vein isolation and linear ablation of the cavotricuspid isthmus will be performed, followed by the same stimulation protocol.
Evaluation of the Extent of Electrical Coupling Between the Vein of Marshall and the Left Atrium
Continuous pacing from the electrode catheter inserted into the vein of Marshall will be performed. During pacing, left atrial mapping will be conducted using a three-dimensional mapping system. The extent of electrical coupling between the vein of Marshall and the left atrium will be evaluated using activation and propagation maps. The extent of electrical coupling is defined as the area where simultaneous excitation occurs during pacing.
Measurement of Biochemical Markers in the Vein of Marshall
Before ablation, a blood sample will be collected from the catheter inserted into the vein of Marshall to measure inflammatory markers and fibrosis markers.
Postoperative Follow-up
For the first two days postoperatively, patients will be monitored via electrocardiogram. Thereafter, follow-up visits will be conducted monthly to evaluate arrhythmia recurrence based on symptoms and ECG findings. If necessary, Holter electrocardiogram monitoring will be performed. Recurrence of atrial arrhythmias is defined as the occurrence of atrial arrhythmias lasting more than 30 seconds, beginning three months after the procedure.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 18 years or older
2) Patients with atrial fibrillation
3) Patients undergoing their initial catheter ablation for atrial fibrillation
4) Patients who have provided written informed consent to participate in this study
Key exclusion criteria
1) Patients with a history of open-heart surgery
2) Patients with impaired renal function (eGFR less than 30)
3) Patients with a contrast agent allergy
4) Patients for whom the use of contrast agents is deemed unsuitable by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakatani |
Organization
Gunma University Graduate School of Medicine
Division name
Division of Non-Pharmacological Management of Cardiac Arrhythmias
Zip code
371-8511
Address
3-39-22 Showamachi, Maebashi, Gunma, Japan
TEL
027-220-8145
yosuke.nakatani@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakatani |
Organization
Gunma University Graduate School of Medicine
Division name
Division of Non-Pharmacological Management of Cardiac Arrhythmias
Zip code
371-8511
Address
3-39-22 Showamachi, Maebashi, Gunma, Japan
TEL
027-220-8145
Homepage URL
yosuke.nakatani@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital
Address
3-39-15 Showamachi, Maebashi, Gunma, Japan
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-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
| 2024 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063835
