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Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers

Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers - Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050926
Enrollment
25
Registered
2023-05-08
Start date
2023-05-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bradyarrhythmia

Interventions

None listed

Sponsors

International University Health and Welfare Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients scheduled for Medtronic leadless maker implantation with atrial mechanical sensing capability in Japan who meet all of the following inclusion criteria. 1) Those who have medical record information during the observation period. 2) Those who have received a full explanation of their participation in this study, and who have obtained the free and voluntary written consent of the patient or a surrogate after full understanding of the situation.

Exclusion criteria

Exclusion criteria: 1) Patients who cannot be expected to have atrial synchronization or ventricular pacing activation 2) Patients suffering from chronic atrial fibrillation 3) Patients who are unable to receive regular post-implantation visits 4) Patients who cannot understand the study 5) Patients deemed inappropriate by the investigator

Design outcomes

Primary

MeasureTime frame
AV synchronization rate (device data AM-Vp and AM-Vs rates) in relation to various parameters 1) Relationship with patient background (age, BMI, NYHA classification, frailty, underlying disease, etc.) 2) Pacemaker parameters at the time of implantation 3) Position of implantation (postoperative imaging: CT, echocardiography) 4) Parameter setting after implantation

Secondary

MeasureTime frame
1) Changes in Cardiac Functional Status by Adjustment of AV Synchronization Ratio 2) Change in AV synchrony rate over time

Countries

Japan

Contacts

Public ContactKOJI FUKUDA

International University Health and Welfare Hospital Arrhythmia Center

fukuda-k@iuhw.ac.jp0287-39-3060

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026