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

Medtronic

Status: Active, not recruiting

Conditions: Bradycardia Sinus; AV Block; Atrial Fibrillation (AF)

Treatments: Other: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT06910059

Micra-CT EM Study

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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