LEAP 2 Chronic EFS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must have at least one standard pacemaker indication
Subject must be at least 18 years of age
Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC
Disqualifiers
Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
Subject has previous myocardial infarction
Subject is expected to be pacemaker dependent
Trial design
Design model
Single group
Treatments tested in this trial
AVEIR CSP Leadless Pacemaker System
DevicePatients will undergo a single or dual-chamber leadless pacemaker system implant wherein an investigational AVEIR CSP leadless pacemaker will be implanted in the right ventricle. Then, a commercial AVEIR AR leadless pacemaker may optionally be co-implanted in the right atrium, if indicated.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Free From AVEIR CSP related Complications at 1-month
AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.
Time frame
1 month2
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month
Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 1 month.
Time frame
1 monthSecondary outcomes
1
Percentage of Participants Free From AVEIR CSP related Complications at 3-months
AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.
Time frame
3 months2
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months
Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 3 months.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov