CompletedNot Applicable

Effect of Leadless Pacing on Heart Function

Belgium51 participantsStarted 2018-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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Inclusion Criteria: * Patients with a Class I or II indication for single chamber pacemaker following international guidelines Exclusion Criteria: * 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.

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT06100757

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-30