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 range18 Years

SexALL

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

What they're measuring

Assessment of ECG characteristics in relation to Micra tip location

Timeframe: Within 6 months after the surgery.

Trial details

NCT IDNCT06910059

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-08-31