Arrhythmia Clinical Trial
— ARRIVEOfficial title:
Aveir AR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
Status | Recruiting |
Enrollment | 586 |
Est. completion date | January 2031 |
Est. primary completion date | January 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study. OR 2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Abbott | Sylmar | California |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute device-related complication rate | Assess the acute (30-day) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant. | 30 days | |
Primary | Two-year survival rate | Assess (2-year) survival rate of subjects implanted with an Aveir AR LP, compared to single chamber atrial transvenous pacemakers. | 2 years | |
Secondary | Chronic complication rate | • To assess the chronic (6-month) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve, occurring more than 30 days through six months post implant. | 6 months | |
Secondary | Device related re-intervention rate | • To assess (2-year) device-related re-intervention rates of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. | 2 years |
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