Brady-tachy SyndromeASCENDNCT07469579
ALPs Single ChambEr New Device Study
A study testing Leadless ventricular pacemaker implantation in people with Brady-tachy Syndrome and Brady Arrythmia, run by Cairdac SA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brady-tachy Syndrome, Brady Arrythmia, Bradycardia
- What is being tested?
- Leadless ventricular pacemaker implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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
- Subject who is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Cairdac study manager.
- Pregnant woman, or woman of childbearing potential and who is not on a reliable form of birth control.
- Subject with exclusion criteria required by local law (e.g. age, breast feeding, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Feasibility Study of the Single Chamber ALPS Leadless Pacemaker System in Patients With Bradycardia
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.
Read the 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 15 participants who will be enrolled and implanted in up to 3 medical centers in Europe. 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
- Brady-tachy Syndrome, Brady Arrythmia, Bradycardia, AV Block, Atrial Fibrillation (Paroxysmal)
- Being tested
- Leadless ventricular pacemaker implantation
- Keywords
- leadless pacemaker, leadless cardiac pacemaker, bradycardia, brady-tachy syndrome, AV block, Atrial Fibrilation, leadless pacing system
- Medical subject headings
- Bradycardia, Atrioventricular Block, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless ventricular pacemaker implantationDevice
Participants will undergo leadless ventricular pacemaker implantation providing pacing therapy by the implant and monitoring using the home monitor.
| Study group | Role | What they receive |
|---|---|---|
| ALPS group | Experimental | A single arm study where all participants will undergo the implantation of ALPS in the heart right ventricle. Receives: Device: Leadless ventricular pacemaker implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device-related serious adverse events
Measured: 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
Measured: 3 months
Secondary outcomes (7)
Rate of patients with battery voltage above 3930mV
Measured: From enrollment to 3 months following the implantation.
The rate of ALPS system and/or procedure-related major complications
Measured: 24 months
The rate of subjects in whom the battery voltage is above 3930mV
Measured: 24 months
The rate of subjects with pacing thresholds that are within therapeutic range
Measured: 24 months
The rate of subjects with therapeutically acceptable sensing amplitude
Measured: 24 months
Rate of patients with pacing impedance is within the acceptable range of 400 - 2000 Ohm
Measured: 24 months
The average voltage of the implant's battery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brady-tachy SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm study where participants will undergo implantation of the ALPS in the right ventricle for a VVI pacing therapy
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairdac SA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469579
- Sponsor's protocol ID
- ALPS-CLNS01-002
- Acronym
- ASCEND
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Single Chamber ALPS Leadless Pacemaker System in Patients With Bradycardia
- ClinicalTrials.gov ID
- NCT07469579
- Acronym / sponsor ID
- ASCEND / ALPS-CLNS01-002
- Conditions
- Brady-tachy Syndrome, Brady Arrythmia, Bradycardia, AV Block, Atrial Fibrillation (Paroxysmal)
- Keywords
- leadless pacemaker, leadless cardiac pacemaker, bradycardia, brady-tachy syndrome, AV block, Atrial Fibrilation, leadless pacing system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cairdac SAUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 15 participants who will be enrolled and implanted in up to 3 medical centers in Europe. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm study where participants will undergo implantation of the ALPS in the right ventricle for a VVI pacing therapy
| Arm | Type | Receives |
|---|---|---|
| ALPS group | Experimental | Device: Leadless ventricular pacemaker implantationA single arm study where all participants will undergo the implantation of ALPS in the heart right ventricle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leadless ventricular pacemaker implantationParticipants will undergo leadless ventricular pacemaker implantation providing pacing therapy by the implant and monitoring using the home monitor. | Device | ALPS group |
Primary outcome
Rate of device-related serious adverse events
Time frame: 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
Time frame: 3 months
7 secondary outcomes
Rate of patients with battery voltage above 3930mV
Time frame: From enrollment to 3 months following the implantation.
The rate of ALPS system and/or procedure-related major complications
Time frame: 24 months
The rate of subjects in whom the battery voltage is above 3930mV
Time frame: 24 months
The rate of subjects with pacing thresholds that are within therapeutic range
Time frame: 24 months
The rate of subjects with therapeutically acceptable sensing amplitude
Time frame: 24 months
Rate of patients with pacing impedance is within the acceptable range of 400 - 2000 Ohm
Time frame: 24 months
The average voltage of the implant's battery
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Brady-tachy Syndrome
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ALPs Single ChambEr New Device
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Leadless ventricular pacemaker implantation in people with Brady-tachy Syndrome and Brady Arrythmia, run by Cairdac SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalit Shav (+33 147 468 515, clinical@cairdac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device-related serious adverse events (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.