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Aveir DR i2i Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05252702
Recruitment Status : Active, not recruiting
First Posted : February 23, 2022
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.

Condition or disease Intervention/treatment Phase
Cardiac Pacemaker, Artificial Cardiac Rhythm Disorder Bradycardia Device: Aveir DR Leadless Pacemaker System Not Applicable

Detailed Description:

The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker.

Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multi-center, international, single-arm, pivotal investigational study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aveir Dual-Chamber Leadless i2i IDE Study
Actual Study Start Date : February 2, 2022
Actual Primary Completion Date : August 2, 2023
Estimated Study Completion Date : November 2025
Arms and Interventions
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Arm Intervention/treatment
Single Arm
Non randomized arm
 Device: Aveir DR Leadless Pacemaker System
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects Free from Aveir DR System-Related Complications [ Time Frame: 3 months ]
    Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects

  2. Number of Subjects Free from Aveir DR System-Related Complications [ Time Frame: 12 months ]
    Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects

  3. Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements [ Time Frame: 3 months ]
    Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects

  4. Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements [ Time Frame: 12 months ]
    Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects

  5. Percentage of Subjects with a Ventricular Beat Followed by an Atrial Beat [ Time Frame: 3 months ]
    AV synchrony success rate at rest while seated in de novo subjects defined as the percentage of subjects with a ventricular paced or sensed beat followed by an atrial paced or sensed beat.


Secondary Outcome Measures :
  1. Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications [ Time Frame: 3 months ]
    Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects

  2. Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications [ Time Frame: 12 months ]
    Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects

  3. Appropriate Rate Response of the Aveir Atrial Leadless Pacemaker During Exercise Testing [ Time Frame: 3 months ]
    Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects during graded exercise testing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 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

Exclusion Criteria:

  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 investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's 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 < 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 leadless pacemaker)
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05252702


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Nicole Harbert Abbott
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT05252702    
Other Study ID Numbers: ABT-CIP-10416
First Posted: February 23, 2022    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Aveir DR i2i Study Steering Committee.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: IPD will be available following publication of primary results for 25 years following study completion date.
Access Criteria: Proposals for requesting individual data may be submitted to the Sponsor at AveirDR_IDE@abbott.com.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Abbott Medical Devices:
Bradycardia
Sick Sinus Syndrome
Pacemaker
AV Block
Vasovagal Syncope
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes