Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07461935
Brief Summary:
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.
Detailed Description:
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 10 participants who will be enrolled and implanted in up to 4 medical centers in the US. 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:
NCT07461935
Study Brief:
Protocol Section:
NCT07461935