Health TrialsbyHealthPanel

Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

ConditionsPacemaker ImplantationAV Node Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

About this trial

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18

permanent pacemaker implantation for AV node disease (first, second or third degree), OR

post-TAVR patient requiring permanent pacemaker implantation

Preserved ejection fraction > 50%

Disqualifiers

Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation

Anatomical restriction for either MICRA or transvenous pacing such as

Access vein occlusion or thrombosis

previous radiation therapy at insertion site

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pacemaker

    Device

    Transvenous pacemaker with left bundle area pacing

  • Pacemaker

    Device

    Transcatheter pacemaker with MICRA AV

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Left bundle area pacingActive comparator 1 intervention
Group B: MICRA AVActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy & Safety

The composite of: 1. procedural success 2. freedom from serious device-related complications at one year 3. freedom from heart failure or drop in ejection fraction below 50%.

Time frame
12 months

Secondary outcomes

1

Procedure time

measured in minutes

Time frame
from procedure start to procedure end
2

Device longevity

device longevity as noted on interrogation reports

Time frame
at 12 month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov
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