The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemak… (NCT06910059) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
China40 participantsStarted 2025-06-17
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of ECG characteristics in relation to Micra tip location