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Completed

NCT Number: NCT05252702

Aveir DR i2i Study

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

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Key information

Conditions

Cardiac Pacemaker, Artificial Arrhythmia, Sinus Arrhythmias, Cardiac Atrioventricular Block Autonomic Nervous System Diseases Bradycardia Cardiac Conduction System Disease Cardiac Rhythm Disorder Cardiovascular Diseases Consciousness Disorders Heart Block Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Dysautonomias Sick Sinus Syndrome Signs and Symptoms Syncope Syncope, Vasovagal Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitätsklinikum GmbH, Linz, Upper Austria, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 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
  • 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
  • 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 leadless pacemaker)
  • 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

Treatment and study plan

Aveir DR Leadless Pacemaker System

Device

Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium

Primary outcomes

  1. Percentage of Participants Free From Aveir DR System-Related Complications at 3-months

    Time frame: 3 months

    Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.

  2. Percentage of Participants Free From Aveir DR System-Related Complications at 12-months

    Time frame: 12 months

    Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.

  3. Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months

    Time frame: 3 months

    Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.

  4. Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months

    Time frame: 12 months

    Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.

  5. Percentage of Participants With AV Synchrony Success Rate at Rest While Seated

    Time frame: 3 months

    AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.

Secondary outcomes

  1. Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months

    Time frame: 3 months

    The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.

  2. Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months

    Time frame: 12 months

    The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.

  3. Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload 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 was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Aveir Dual-Chamber Leadless i2i IDE Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Feb 23, 2022
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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