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Effect of Leadless Pacing on Heart Function

NCT06100757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-10-31

No results posted yet for this study

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 to undergo the implantation of a conventional VVI pacing system (Medtronic, Advisa ADSR03) with a ventricular pacing lead (Medtronic, 5076-58) in the right ventricle (called 'conventional group') or to be implanted with a leadless Micra TPS (called 'Micra group').

The primary objective was to assess and compare the mechanical impact of right ventricular pacing using the Micra TPS versus a conventional PM on the left ventricular function.

Conditions

  • Pacing-Induced Cardiomyopathy

Interventions

DEVICE

Micra Transcatheter Pacing System (TPS°

Implantation of a leadless pacemaker type Micra TPS. Echocardiographic and clinical follow-up during 12 months

DEVICE

Conventional pacemaker type Medtronic Advisa ADSR03 or Azure XT VR

Implantation of a conventional ventricular pacemaker (VVI and VV(R) pacing mode) and right ventricular lead (Medtronic 5076-58)/ Echocardiographic and clinical follow-up during 12 months

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Christophe Garweg, MD, PhD · University hospitals of Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100757 on ClinicalTrials.gov