Clinical trial NCT06910059: The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
Official title: The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bradycardia Sinus
AV Block
Atrial Fibrillation (AF)
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll up to 40 subjects in site. Patients with pacing indications who plan to receive Micra AV implantation will be selected.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of ECG characteristics in relation to Micra tip location
timeFrame: Within 6 months after the surgery.
Secondary outcomes:
measure: Cardiac functional changes
timeFrame: Within 6 months after the surgery.
measure: To investigate whether Micra location would impact AV synchrony
timeFrame: Within 6 months after the surgery.
Other outcomes:
Locations:
city: Urumqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References:
citation: Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada J, Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei MA, Laager V, Stromberg K, Williams ER, Hudnall JH, Ritter P; Micra Transcatheter Pacing Study Group. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Feb 11;374(6):533-41. doi: 10.1056/NEJMoa1511643. Epub 2015 Nov 9.
citation: Udo EO, Zuithoff NP, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA, Moons KG. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012 May;9(5):728-35. doi: 10.1016/j.hrthm.2011.12.014. Epub 2011 Dec 17.
citation: Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18):1186-94. doi: 10.1093/eurheartj/eht511. Epub 2013 Dec 17.