ALPs Single ChambEr New Device Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairdac SA
About this trial
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, ≥ 18 years of age at enrolment
Paroxysmal or permanent high-grade AV block in the presence of Atrial Fibrillation (AF)
Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
Symptomatic bradycardia-tachycardia syndrome or Sinus Node Dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
Disqualifiers
Subject who is entirely pacemaker dependent (escape rhythm <30 bpm).
Subject has an existing or prior pacemaker, ICD, or CRT device implant.
Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
Subject had recent cardiovascular or peripheral vascular surgery within 30 days prior to enrollment
Trial design
Design model
Single group
Treatments tested in this trial
Leadless ventricular pacemaker implantation
DeviceParticipants will undergo leadless ventricular pacemaker implantation providing pacing therapy by the implant and monitoring using the home monitor.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: ALPS groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of device-related serious adverse events
Time frame
3 months2
Rate of participants with pacing thresholds (PCT) ≤ 2V at 0.4 ms pulse width, and and an increase in PCT from implantation is less than 1.5V, and R-wave amplitudes ≥ 5.0 mV, or a value ≥ the value at implantation
Time frame
3 monthsSecondary outcomes
1
Rate of patients with battery voltage above 3930mV
Time frame
From enrollment to 3 months following the implantation.2
The rate of ALPS system and/or procedure-related major complications
Time frame
24 months3
The rate of subjects in whom the battery voltage is above 3930mV
Time frame
24 months4
The rate of subjects with pacing thresholds that are within therapeutic range
Time frame
24 monthsLocations
Source ClinicalTrials.gov
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