Not Yet RecruitingNot Applicable

ALPs Single ChambEr New Device Study

15 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female, ≥ 18 years of age at enrolment
✓. Subject who has a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS/EHRA guidelines:
✓. Paroxysmal or permanent high-grade AV block in the presence of Atrial Fibrillation (AF)
✓. Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
✓. Symptomatic bradycardia-tachycardia syndrome or Sinus Node Dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
✓. Subject able and willing to undergo the study requirements and is expected to be geographically stable for the duration of the follow-up.
✓. Subject with a life expectancy of more than 24 months.
✓. Subject is able and willing to use the Home Monitor.

Exclusion criteria

✕. Subject who is entirely pacemaker dependent (escape rhythm \<30 bpm).
✕. Subject has an existing or prior pacemaker, ICD, or CRT device implant.
✕. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
✕. Subject had recent cardiovascular or peripheral vascular surgery within 30 days prior to enrollment
✕. Subject with current implantation of a neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
✕. Subject with a prior intervention of the tricuspid valve, implanted vena cava filter that cannot be crossed, or left ventricular assist device (LVAD).
✕. Subject who is morbidly obese (BMI \> 40).
✕. Subject who has a below normal BMI (BMI\<18).

What they're measuring

Rate of device-related serious adverse events

Timeframe: 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

Timeframe: 3 months

Trial details

NCT IDNCT07469579

SponsorCairdac SA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Dalit Shav

+33 147 468 515 clinical@cairdac.com

View on ClinicalTrials.gov More Brady-tachy Syndrome trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female, ≥ 18 years of age at enrolment
✓. Subject who has a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS/EHRA guidelines:
✓. Paroxysmal or permanent high-grade AV block in the presence of Atrial Fibrillation (AF)
✓. Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
✓. Symptomatic bradycardia-tachycardia syndrome or Sinus Node Dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
✓. Subject able and willing to undergo the study requirements and is expected to be geographically stable for the duration of the follow-up.
✓. Subject with a life expectancy of more than 24 months.
✓. Subject is able and willing to use the Home Monitor.

Exclusion criteria

✕. Subject who is entirely pacemaker dependent (escape rhythm \<30 bpm).
✕. Subject has an existing or prior pacemaker, ICD, or CRT device implant.
✕. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
✕. Subject had recent cardiovascular or peripheral vascular surgery within 30 days prior to enrollment
✕. Subject with current implantation of a neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
✕. Subject with a prior intervention of the tricuspid valve, implanted vena cava filter that cannot be crossed, or left ventricular assist device (LVAD).
✕. Subject who is morbidly obese (BMI \> 40).
✕. Subject who has a below normal BMI (BMI\<18).

What they're measuring

Rate of device-related serious adverse events

Timeframe: 3 months