NCT06100757

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

3.6 years

First QC Date

October 20, 2023

Last Update Submit

October 26, 2023

Conditions

Pacing-Induced Cardiomyopathy

Keywords

leadless pacemakerMicra Transcatheter pacemakerventricular functionvalve function

Outcome Measures

Primary Outcomes (1)

  • Assessment and comparison of the mechanical impact of right ventricular pacing using the Micra TPS versus a conventional PM on the left ventricular function.

    The primary endpoints were the change in left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS)

    1 year

Secondary Outcomes (3)

  • Evolution of the right ventricular, tricuspid valve and mitral valve function

    1 year

  • Evolution of NT-pro-BNP

    1 year

  • Evolution of pacemaker performance

    1 year

Study Arms (2)

Conventional pacing

ACTIVE COMPARATOR

24 patients underwent the implantation of a conventional VVI pacing system (Medtronic) with placement of a ventricular pacing lead Medtronic 5076-58 in the right ventricle.

Device: Conventional pacemaker type Medtronic Advisa ADSR03 or Azure XT VR

leadless pacing

EXPERIMENTAL

27 patients underwent the implantation of a leadless pacing system Micra TPS

Device: Micra Transcatheter Pacing System (TPS°

Interventions

Micra Transcatheter Pacing System (TPS°DEVICE

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

leadless pacing
Conventional pacemaker type Medtronic Advisa ADSR03 or Azure XT VRDEVICE

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

Conventional pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a Class I or II indication for single chamber pacemaker following international guidelines

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Garweg C, Duchenne J, Vandenberk B, Mao Y, Ector J, Haemers P, Poels P, Voigt JU, Willems R. Evolution of ventricular and valve function in patients with right ventricular pacing - A randomized controlled trial comparing leadless and conventional pacing. Pacing Clin Electrophysiol. 2023 Dec;46(12):1455-1464. doi: 10.1111/pace.14870. Epub 2023 Nov 13.

    PMID: 37957879DERIVED

Study Officials

  • Christophe Garweg, MD, PhD

    University hospitals of Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

May 1, 2018

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)