NCT07461935

ALPs Single ChambEr New Device

Early Feasibility Study of the Single Chamber ALPS Leadless Pacemaker System in Patients With Bradycardia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cairdac SA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia
• Brady-tachy Syndrome
• AV Block
• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DEVICE	Leadless ventricular pacemaker implantation	Participants will undergo leadless ventricular pacemaker implantation providing pacing therapy by the implant and monitoring using the home monitor.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-03-01
• Completion: 2028-12-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Regulatory

• FDA-regulated device study