Unique ID issued by UMIN | UMIN000030750 |
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Receipt number | R000035040 |
Scientific Title | Clinical Significance of Injury Current Analysis after Permanent Leadless Cardiac Pacemaker Implantation |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2018/01/10 17:21:06 |
Clinical Significance of Injury Current Analysis after Permanent Leadless Cardiac Pacemaker Implantation
Clinical Significance of Injury Current Analysis after Permanent Leadless Cardiac Pacemaker Implantation
Clinical Significance of Injury Current Analysis after Permanent Leadless Cardiac Pacemaker Implantation
Clinical Significance of Injury Current Analysis after Permanent Leadless Cardiac Pacemaker Implantation
Japan |
Bradyarrhythmia
Cardiology |
Others
NO
To determine whether injury current on the intracardiac electrogram is correlated with adequate fixation in permanent leadless cardiac pacemaker implantation.
Efficacy
To clarify the useful parameters of an injury current at the time of leadless pacemaker implantation for expecting future stable pacing and sensing thresholds.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Consecutive patients who underwent a leadless pacemaker implantation according to guideline-based indications for ventricular pacemaker implantation.
2) The patients who are able to follow up over 6 months.
1) Patients without a clinical indication for leadless pacemaker implantation.
2) Patients that had a past history with unstable angina or acute myocardial infarction or coronary revascularization within 30 days.
3) Patients who had a mechanical tricuspid valve replacement, or have a schedule to receive tricuspid valve repair or replacement.
4) The patients with life expectancy within 6 months.
5) Patients with pregnancy.
6) Patients who rejected the inclusion in this study.
50
1st name | |
Middle name | |
Last name | Masue Yoh |
Kansai Medical University Medical Center
Division of Cardiology, Nephrology, and Endocrinology and Metabolism
10-15 Fumizono-cho, Moriguchi, Osaka
(06)6992-1001
yohm@mc.kmu.ac.jp
1st name | |
Middle name | |
Last name | Masue Yoh |
Kansai Medical University Medical Center
Division of Cardiology, Nephrology, and Endocrinology and Metabolism
10-15 Fumizono-cho, Moriguchi, Osaka
(06)6992-1001
yohm@mc.kmu.ac.jp
Kansai Medical University Medical Center
None
Self funding
NO
関西医科大学総合医療センター(大阪府)/ Kansai Medical University Medical Center
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2017 | Year | 12 | Month | 10 | Day |
2018 | Year | 04 | Month | 01 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
Prospective study.
Patients who underwent implantation of the leadless cardiac pacemaker from approval to December 2022.
We are planning to perform a blood test, analysis of intracardiac electrograms, telemetry findings, and a predicted battery life, orientation of pacemaker on chest X-ray.
2018 | Year | 01 | Month | 10 | Day |
2018 | Year | 01 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035040
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