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Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIRâ„¢ Conduction System Pacing (CSP) Leadless Pacemaker system.
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, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVEIR CSP Leadless Pacemaker System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Y Reddy, MD | The Mount Sinai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolce | Prague | Czechia |
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
IPD will be available following publication of primary results for 25 years following study completion date.
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective, single-arm, non-randomized, unblinded, chronic feasibility study
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Pacing Thresholds at 0.4 ms pulse width and sense amplitudes of the AVEIR CSP LP by capture type at 3 months. |
| 3 months |
| D001146 | Arrhythmia, Sinus |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |