Status:
COMPLETED
Effect of Leadless Pacing on Heart Function
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Medtronic
Conditions:
Pacing-Induced Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective, un-blinded, randomized, noninferiority, single centre study with 12 month follow-up included patients who were scheduled for a single-chamber PM implant. Patients were 1:1 randomized...
Detailed Description
The primary endpoint was to assess the mechanical impact of the Micra TPS on the left ventricular function. The investigators measured the change of Global Longitudinal Strain (GLS) over one year afte...
Eligibility Criteria
Inclusion
- Patients with a Class I or II indication for single chamber pacemaker following international guidelines
Exclusion
- patients with previously implanted cardiac devices / mechanical valves that would interfere with the echocardiographic measurements
- patients with inadequate image quality at baseline that prohibited the assessment of myocardial mechanics using echocardiography
- patients with a left ventricular ejection fraction (LVEF) ≤40% at baseline
- patients considered to have a pre-existing condition challenging/precluding the implant of a conventional pacemaker
- patients who refused or were not able to provide written informed consent.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06100757
Start Date
May 1 2018
End Date
December 31 2021
Last Update
October 31 2023
Active Locations (1)
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1
University Hospitals of Leuven
Leuven, Belgium, 3000