臨床研究等提出・公開システム

Aveir Dual-Chamber Leadless i2i IDE Study

Aveir DR i2i Study

Nicole Harbert

Abbott

6901 Preston Road, Plano, TX, 75204, US

nicole.harbert@abbott.com

Hanada Kozo

Abbott Medical Japan LLC

Hamarikyu Park Side Place 9F, 5-6-10 Tsukiji, Chuo-ku, Tokyo

+81-3-3524-1792

kozo.hanada@abbott.com

Complete

Aug. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
2. Subject is 18 and over years of age or age of legal consent, whichever age is greater
3. Subject has a life expectancy of at least one year
4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC

1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
3. Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigators opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subjects ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
4. Subject has a known allergy or hypersensitivity to less than 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU
5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular LP)
9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)*
10. Subject is unable to read or write
*NOTE: Does not apply to a medical device with no known impact to the Aveir Leadless Pacemaker System, including the Aveir Link Module. Patient evaluation and the decision to implant the LP should take into account the presence of other active implantable devices and should include consultation with the Sponsor and/or manufacturer of the co-existing device.

Both

Patients who are indicated for a DDD(R) pacemaker

The invesitgateional device will be implanted for the patient who needs dual chamber pacemaker therapy.

Bradycardia, Sick Sinus Syndrome,Pacemaker, AV Block, Vasovagal Syncope

Primary Safety Endpoint:
The primary safety endpoint evaluates the 3-month Aveir DR LP system Complication Free Rate (CFR) in
de novo subjects based on CEC adjudication of adverse events.
Primary Effectiveness Endpoint#1:
The primary effectiveness endpoint #1 evaluates the 3-month composite success rate of acceptable atrial
pacing thresholds and P-wave amplitudes in de novo subjects.
Primary Effectiveness Endpoint#2:
The primary effectiveness endpoint #2 evaluates the 3-month AV-synchrony success rate at rest while
seated in de novo subjects.

Secondary Safety Endpoint:
The secondary safety endpoint evaluates the Aveir Atrial LP complication free rate (CFR) at 3-months
post-implant in de novo subjects based on CEC adjudication of adverse events.

+81-6-6170-1070

+81-3-3353-8111

+81-86-422-0210

+81-93-511-2000

No

Canada/Czech Republic/France/Germany/Hong Kong/Italy/Japan/Netherlands/Spain/Taiwan/United Kingdom/USA