The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-17

Study Completion Date

2026-06-30

Brief Summary

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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 Micra pacing location to improve LV function, (2) to investigate the correlation between Micra tip location and tricuspid regurgitation, and (3) to investigate whether Micra location would impact AV synchrony. Patients with pacing indications who plan to receive Micra AV implantation will be recruited.

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Detailed Description

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Conditions

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Bradycardia Sinus AV Block Atrial Fibrillation (AF)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Observational

It is a observational study and patients with pacing indications who plan to receive Micra AV implantation will be recruited. No intervention procedure will be performed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No