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Clinical Trials/jRCT2052220049
jRCT2052220049CompletedNot Applicable

Aveir Dual-Chamber Leadless i2i IDE Study

Abbott Medical Japan LLC0 sites550 target enrollmentStarted: November 25, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
550
Primary Endpoint
Primary Safety Endpoint
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study
Intervention Model
Single Assignment
Primary Purpose
Treatment Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
18age old over to No limit (—)
Sex
All

Inclusion Criteria

  • •Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
  • •Subject is 18 and over years of age or age of legal consent, whichever age is greater
  • •Subject has a life expectancy of at least one year
  • •Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
  • •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

Exclusion Criteria

  • •Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
  • •Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
  • •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
  • •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
  • •Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
  • •Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
  • •Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
  • •Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular LP)
  • •Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)*
  • •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.

Outcomes

Primary Outcomes

Primary Safety Endpoint

Time Frame: 3-month

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

Time Frame: 3-month

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

Time Frame: 3-month

The primary effectiveness endpoint #2 evaluates the 3-month AV-synchrony success rate at rest while seated in de novo subjects.

Secondary Outcomes

  • Aveir Atrial LP complication free rate (CFR) at 3-months post-implant(3-months post-implant)

Investigators

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