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

NCT06910059 | Active Not Recruiting

• 1 other identifier: Micra-CT EM Study
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

AV Block; Atrial Fibrillation (AF); Bradycardia Sinus

Outcome Measures

Primary Outcomes (1)

• Assessment of ECG characteristics in relation to Micra tip location

  Patients' ECG will be measured to see whether there is difference in ECG characteristics between Micra tip locations.

  Within 6 months after the surgery.

Secondary Outcomes (2)

• Cardiac functional changes

  Within 6 months after the surgery.

• To investigate whether Micra location would impact AV synchrony

  Within 6 months after the surgery.

Interventions

Observational OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Related Publications (3)

• 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.

  PMID: 26551877 RESULT

• 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.

  PMID: 22182495 RESULT

• 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.

  PMID: 24347317 RESULT

MeSH Terms

Conditions

Atrioventricular Block; Atrial Fibrillation

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 4, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)