Bradycardia, Cardiac Pacemaker, Cardiac Rhythm Disorder
Conditions
Keywords
Bradycardia, Sick Sinus Syndrome, Pacemaker, Leadless, Conduction System Pacing, LBBAP
Brief 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.
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
Interventions
DEVICEAVEIR 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.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Free From AVEIR CSP related Complications at 1-month | 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 | 1 month | Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 1 month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Free From AVEIR CSP related Complications at 3-months | 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. |
| Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months | 3 months | Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 3 months. |
Countries
Czechia
Contacts
CONTACTKwangdeok Lee, PhD
PRINCIPAL_INVESTIGATORVivek Y Reddy, MD
The Mount Sinai Hospital
Outcome results
None listed