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
Qualifiers
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
Treatments tested in this trial
- Leadless ventricular pacemaker implantation
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
This trial has no locations
Sponsors and collaborators
Cairdac SA
Lead sponsor
Source ClinicalTrials.gov