ALPs Single ChambEr New Device

Sponsor
Cairdac SA
Study ID
NCT07461935
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 10, 2026
Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ALPS group
    It is a single arm study where participants will undergo the implantation of ALPS in the heart right ventricle.

Primary Outcome Measure

Rate of device-related serious adverse events [ Time Frame: 3 months ]

Central Contacts

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