UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059163 |
|---|---|
| Receipt number | R000067570 |
| Scientific Title | Effect of Atrioventricular Synchronous Pacing with Atrial Mechanical Sensing of Micra AV on Cardiac Output and Exercise Tolerance Micra |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/22 21:38:40 |
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Basic information
Public title
Effect of Atrioventricular Synchronous Pacing with Atrial Mechanical Sensing of Micra AV on Cardiac Output and Exercise Tolerance Micra
Acronym
Effect of Atrioventricular Synchronous Pacing with Atrial Mechanical Sensing of Micra AV on Cardiac Output and Exercise Tolerance Micra
Scientific Title
Effect of Atrioventricular Synchronous Pacing with Atrial Mechanical Sensing of Micra AV on Cardiac Output and Exercise Tolerance Micra
Scientific Title:Acronym
Effect of Atrioventricular Synchronous Pacing with Atrial Mechanical Sensing of Micra AV on Cardiac Output and Exercise Tolerance Micra
Region
| Japan |
Condition
Condition
Patients with high-degree atrioventricular block or complete atrioventricular block who are candidates for leadless pacemaker implantation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether atrial mechanical sensing-based atrioventricular (AV) synchronous pacing using the Micra AV leadless pacemaker can improve cardiac output, hemodynamics, and exercise tolerance compared to the conventional VVI pacing mode.
Hemodynamic parameters such as cardiac output are assessed using a Swan-Ganz catheter (thermaldilution catheter) and a non-invasive cardiac output monitor. Exercise capacity is evaluated using a cardiopulmonary exercise test (CPX).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Exercise capacity evaluation using CPX
Key secondary outcomes
- Various parameters of Swan-Ganz catheter
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with high-degree atrioventricular block or complete atrioventricular block who are candidates for leadless pacemaker implantation.
Key exclusion criteria
Patients who are eligible for implantation of a transvenous subcutaneous implantable pacemaker
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Minami |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL
0282-86-1111
k-minami@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Minami |
Organization
Dokkyo Medical University
Division name
Department of Cardiovascular Medicine
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL
0282-86-1111
Homepage URL
k-minami@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi
Tel
0282-86-1111
r-kenkyu@dokkyomed.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 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067570
