Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
304 participants
OBSERVATIONAL
2025-05-26
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Analysis Cohort
This survey targets the registration of 194 patients indicated for de novo dual-chamber LP's. All de novo patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up
Aveir DR Leadless Pacemaker Implant
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Single-chamber atrial Aveir patients
Up to 50 patients indicated for a de novo atrial LP may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up
Single-chamber atrial Aveir patients
Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium
Upgrade Patients
Up to 36 upgrade patients (existing ventricular LP to dual-chamber LP system or existing atrial LP to dual-chamber LP system) may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up
Upgrades
Patients with an existing single-chamber leadless pacemaker will undergo a leadless pacemaker system implant wherein an additional leadless pacemaker will be implanted in either the right ventricle or right atrium to form a dual-chamber LP system.
Rollover
All patients from Japan sites with existing active Aveir LPs from the Aveir DR IDE i2i Study (up to 24 patients) are eligible to roll over into the Aveir Japan PMS upon consent for ongoing follow-up. Data from the rollover patients will be summarized separately. Rollover patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up
Roll-over
Patients with an existing active Aveir DR leadless pacemaker system are eligible to be rolled into the Aveir Japan PMS upon consent for ongoing follow-up.
Interventions
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Aveir DR Leadless Pacemaker Implant
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Single-chamber atrial Aveir patients
Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium
Upgrades
Patients with an existing single-chamber leadless pacemaker will undergo a leadless pacemaker system implant wherein an additional leadless pacemaker will be implanted in either the right ventricle or right atrium to form a dual-chamber LP system.
Roll-over
Patients with an existing active Aveir DR leadless pacemaker system are eligible to be rolled into the Aveir Japan PMS upon consent for ongoing follow-up.
Eligibility Criteria
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Inclusion Criteria
* Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study
* Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system
Exclusion Criteria
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagwa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Osaka Keisatsu Hospital
Osaka, Osaka, Japan
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, Japan
Juntendo University Shizuoka Hospital
Izunokuni, Shizuok, Japan
Tokyo Medical University Hospital
Tokyo, Tokyo, Japan
Tokyo Women's Hospital
Tokyo, Tokyo, Japan
Countries
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Central Contacts
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Facility Contacts
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Kengo Kusano, MD
Role: primary
Other Identifiers
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CL1027565
Identifier Type: -
Identifier Source: org_study_id
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