ALPs Single ChambEr New Device

NCT07461935 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: ALPS-CLNS01-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

leadless pacemaker; ventricular leadless pacemaker; Bradycardia; Brady-tachy syndrome; AV block; Atrial Fibrillation; pacemaker; leadless cardiac pacemaker; leadless pacing system; delivering leadless system; permanent leadless pacemaker; single chamber leadless pacemaker; single chamber leadless pacing therapy; VVI; autonomous leadless pacing system; piezoelectric energy harvester; VOO; home monitor; home monitoring; remote monitoring

Outcome Measures

Primary Outcomes (2)

• Rate of device-related serious adverse events

  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

  3 months

Secondary Outcomes (7)

• Rate of patients with battery voltage above 3930mV

  3 months

• The rate of ALPS system and/or procedure-related major complications

  24 months

• The rate of subjects in whom the battery voltage is above 3930mV

  24 months

• The rate of subjects with pacing thresholds that are within therapeutic range

  24 months

• The rate of subjects with therapeutically acceptable sensing amplitude

  24 months

Study Arms (1)

ALPS group

EXPERIMENTAL

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

Device: Leadless ventricular pacemaker implantation

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.

ALPS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure.

You may not qualify if:

• 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).
• Subject whose femoral venous anatomy is unable to accommodate a 24 French introducer sheath or an implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.
• Subject with ventricular dysfunction and LVEF ≤ 50
• Subject who is considered as unable to tolerate an urgent sternotomy.
• Subject with a known intolerance to Titanium, titanium nitride, parylene C, PEEK, platinum-iridium alloy, heparin, or sensitivity to contrast media.
• Subject for whom a single dose of 1.0 mg dexamethasone acetate may be contraindicated.
• Subject with a life expectancy of less than 24 months.
• Subject with significant co-morbid conditions or other conditions which, at the discretion of the PI, are deemed to prohibit study entry

Sponsors & Collaborators

• Cairdac SA: lead

MeSH Terms

Conditions

Bradycardia; Atrioventricular Block; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Central Study Contacts

Dalit Shav

CONTACT

+33 147 468 515; clinical@cairdac.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single arm study where participants will undergo implantation of the ALPS in the right ventricle for a VVI pacing therapy

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03