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Active, Not Recruiting

NCT Number: NCT06910059

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bradycardia Sinus AV Block Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Atrioventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of ECG characteristics in relation to Micra tip location

    Time frame: Within 6 months after the surgery.

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

Secondary outcomes

  1. Cardiac functional changes

    Time frame: Within 6 months after the surgery.

    LVEF, RV length and quantity of tricuspid regurgitation will be measured.

  2. To investigate whether Micra location would impact AV synchrony

    Time frame: Within 6 months after the surgery.

    Percentage of AV synchrony will be measured.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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