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Clinical Trials in Czechia / NCT07287423
Recruiting Not applicable

LEAP 2 Chronic EFS

NCT07287423 · tracked via the Priya Life Science Czechia tracker
Phase
Not applicable
Started
2025-12-13
Last updated
2026-07-15

Condition(s) studied

Cardiac PacemakerCardiac Rhythm DisorderBradycardia

Investigational drug(s) / intervention(s)

AVEIR CSP Leadless Pacemaker System

AVEIR CSP Leadless Pacemaker System: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject must have at least one standard pacemaker indication 2. Subject must be at least 18 years of age 3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams 4. 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 Exclusion Criteria: 1. Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter 2. Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure 3. Subject has previous myocardial infarction 4. Subject is expected to be pacemaker dependent 5. 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) 6. Subject has an active implantable electronic device that cannot be turned off during the study procedure 7. Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment 8. 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 9. Subject is unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 10. Subject has known chronic renal insufficiency including patients on dialysis 11. Subject has an active systemic infection 12. Subject has known history or repair of an atrial septal defect, patent foramen ovale, or ventricular septal defect 13. Subject is currently participating in another clinical investigation that might impact the outcomes of the clinical investigation 14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 15. 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 16. Subject is unable to read or write

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nemocnice Na Homolce Prague Czechia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07287423 on ClinicalTrials.gov ↗ ← All trials in Czechia