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ALPs Single ChambEr New Device

NCT07461935 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Leadless ventricular pacemaker implantation

Participants will undergo leadless ventricular pacemaker implantation providing pacing therapy by the implant and monitoring using the home monitor.

Sponsors & Collaborators

  • Cairdac SA

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-03-31
Completion
2028-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07461935 on ClinicalTrials.gov