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Aveir Leadless Pacemaker Japan PMS

Recruitingn/aAges any - anyAllAbbott Medical Devices
NCT07106788 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system * 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: * N/A
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What it tests

  • Aveir DR Leadless Pacemaker Implant
  • Single-chamber atrial Aveir patients
  • Upgrades
  • Roll-over
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Where

14 sites
Nagoya University Hospital
Nagoya, Japan
Kokura Memorial Hospital
Kitakyushu, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Japan
Sendai Kousei Hospital
Sendai, Japan
Kurashiki Central Hospital
Kurashiki, Japan
Kansai Medical University Hospital
Hirakata, Japan
Osaka Keisatsu Hospital
Osaka, Japan
National Cerebral & Cardiovascular Center Hospital
Suita, Japan

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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