Status:
ACTIVE_NOT_RECRUITING
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Bradycardia Sinus
AV Block
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location. The secondary objective is (1) to identify an optimal ...
Eligibility Criteria
Inclusion
- Patients aged above 18 years old
- Patients who are willing to provide Informed Consent
- Patients with Class I or II indications who plan to receive a leadless pacemaker, including SSS, AVB, AF with bradycardia, etc.
- Patients who plan to conduct a cardiac CT scan after implantation
Exclusion
- Patients with lead retention
- Patients had heart valve replacement
- Patients diagnosed with ischemic heart diseases
- Patients who are allergic to or refuse to use contrast in CT scans
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients with medical conditions that would limit study participation
- Patients already enrolled in another clinical trial which would impact participation of this study
Key Trial Info
Start Date :
June 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06910059
Start Date
June 17 2025
End Date
June 30 2026
Last Update
July 3 2025
Active Locations (1)
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1
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China