Cardiac PacemakerNCT07287423
LEAP 2 Chronic EFS
A study testing AVEIR CSP Leadless Pacemaker System in people with Cardiac Pacemaker and Cardiac Rhythm Disorder, run by Abbott Medical Devices at 1 site in Czechia.
Trial summary
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- What is being tested?
- AVEIR CSP Leadless Pacemaker System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 13 Dec 2025to 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
- Subject must have at least one standard pacemaker indication
- Subject must be at least 18 years of age
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
- Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC
Who cannot join
- Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
- Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
- Subject has previous myocardial infarction
- Subject is expected to be pacemaker dependent
- Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)
- Subject has an active implantable electronic device that cannot be turned off during the study procedure
Show all 16Show fewer
- Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
- Subject has known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure
- Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Subject has known chronic renal insufficiency including patients on dialysis
- Subject has an active systemic infection
- Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect
- Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the follow-up requirements of the clinical investigation
- Subject is unable to read or write
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: LEadless Advanced Pacing 2 Chronic Early Feasibility Study
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
Read the detailed description
The purpose of this clinical investigation is to evaluate the chronic safety and performance of the AVEIR CSP Leadless Pacemaker system in a patient population with standard pacing indications.
Subjects participating in the study will have data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 2 months, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Being tested
- AVEIR CSP Leadless Pacemaker System
- Keywords
- Bradycardia, Sick Sinus Syndrome, Pacemaker, Leadless, Conduction System Pacing, LBBAP
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVEIR CSP Leadless Pacemaker SystemDevice
Patients will undergo a single or dual-chamber leadless pacemaker system implant wherein an investigational AVEIR CSP leadless pacemaker will be implanted in the right ventricle. Then, a commercial AVEIR AR leadless pacemaker may optionally be co-implanted in the right atrium, if indicated.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Device: AVEIR CSP Leadless Pacemaker System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Free From AVEIR CSP related Complications at 1-month
AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.
Measured: 1 month
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month
Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 1 month.
Measured: 1 month
Secondary outcomes (2)
Percentage of Participants Free From AVEIR CSP related Complications at 3-months
AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.
Measured: 3 months
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months
Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start13 Dec 2025
- Primary completionJul 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 Cardiac PacemakerStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Prospective, single-arm, non-randomized, unblinded, chronic feasibility study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Y Reddy, MD, Principal investigator, The Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287423
- Sponsor's protocol ID
- ABT-CIP-10614
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Study Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEadless Advanced Pacing 2 Chronic Early Feasibility Study
- ClinicalTrials.gov ID
- NCT07287423
- Acronym / sponsor ID
- ABT-CIP-10614
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Keywords
- Bradycardia, Sick Sinus Syndrome, Pacemaker, Leadless, Conduction System Pacing, LBBAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Dec 2025 (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, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
Detailed description
The purpose of this clinical investigation is to evaluate the chronic safety and performance of the AVEIR CSP Leadless Pacemaker system in a patient population with standard pacing indications.
Subjects participating in the study will have data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 2 months, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, non-randomized, unblinded, chronic feasibility study
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: AVEIR CSP Leadless Pacemaker System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must have at least one standard pacemaker indication
- Subject must be at least 18 years of age
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
- Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC
Key exclusion criteria (16 listed)
- Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
- Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
- Subject has previous myocardial infarction
- Subject is expected to be pacemaker dependent
- Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)
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 |
|---|---|---|
| AVEIR CSP Leadless Pacemaker SystemPatients will undergo a single or dual-chamber leadless pacemaker system implant wherein an investigational AVEIR CSP leadless pacemaker will be implanted in the right ventricle. Then, a commercial AVEIR AR leadless pacemaker may optionally be co-implanted in the right atrium, if indicated. | Device | Treatment Arm |
Primary outcome
Percentage of Participants Free From AVEIR CSP related Complications at 1-month
Time frame: 1 month
AVEIR CSP Leadless Pacemaker (LP) System complication-free-rate. A complication is defined as an AVEIR CSP LP device or AVEIR CSP procedure-related serious adverse event.
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month
Time frame: 1 month
Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 1 month.
2 secondary outcomes
Percentage of Participants Free From AVEIR CSP related Complications at 3-months
Time frame: 3 months
Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months
Time frame: 3 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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Study Principal Investigator
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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.
Vivek Y Reddy, MD principal investigator
The Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVEIR CSP Leadless Pacemaker System in people with Cardiac Pacemaker and Cardiac Rhythm Disorder, run by Abbott Medical Devices at 1 site in Czechia.
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 4 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Kwangdeok Lee, PhD (972-526-9673, kwangdeok.lee@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Free From AVEIR CSP related Complications at 1-month (time frame: 1 month). 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 16 Oct 2026.