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.
The objective of this clinical trial is to assess the initial safety and performance of the autonomous leadless pacing system (ALPS) when used in patients with bradycardia. The ALPS™ is a system consisting of a leadless pacemaker, a catheter, a programmer and a home monitor. The ALPS leadless pacemaker is intended to sense the electrical activity of the heart and to provide cardiac pacing therapy in patients requiring VVI therapy. The ALPS has an energy harvester that provides the energy for the pacing therapy and communication with a home monitor, instead of a battery limited in its life time. The study will include up to 15 participants who will be enrolled and implanted in up to 3 medical centers in Europe. The duration of participation for each participant will be 24 months. Participants will be evaluated 1 month, 3, 6, 12, 18 and 24 months following the implantation. The study includes safety assessment which consists of checking for device or procedure-related major complications. The performance assessment consists of collecting and analyzing the leadless pacemaker's battery voltage and pacing parameters. In addition, the study will collect data to analyze the performance of the energy harvester.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Participants will undergo leadless ventricular pacemaker implantation providing pacing therapy by the implant and monitoring using the home monitor.
Rate of device-related serious adverse events
Time frame: 3 months
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 months
Rate of patients with battery voltage above 3930mV
Time frame: From enrollment to 3 months following the implantation.
The rate of ALPS system and/or procedure-related major complications
Time frame: 24 months
The rate of subjects in whom the battery voltage is above 3930mV
Time frame: 24 months
The rate of subjects with pacing thresholds that are within therapeutic range
Time frame: 24 months
The rate of subjects with therapeutically acceptable sensing amplitude
Time frame: 24 months
Rate of patients with pacing impedance is within the acceptable range of 400 - 2000 Ohm
Time frame: 24 months
The average voltage of the implant's battery
Time frame: 24 months
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