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

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

NCT06910059•Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (1)

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Key Dates

Start Date

June 17, 2025

Primary Completion Date

April 30, 2026

Completion Date

June 30, 2026

Last Updated

July 3, 2025

Enrollment

ESTIMATED participants

Conditions

Bradycardia SinusAV BlockAtrial Fibrillation (AF)

Interventions

Observational

OTHER

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Atrial Fibrillation (AF)

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

Exercise and Dietary Lifestyle Intervention on Reducing Atrial Fibrillation Burden, Cardiac and Body Fat Mass.

Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

Electroporation Treatment for Early AF Management in Heart Failure With Preserved Ejection Fraction (HFpEF) Pilot Study

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Efficacy and Safety of Micra AV2 Transcatheter Pacing System