N/A Completed N=464 Treatment

Aveir DR i2i Study

Cardiac Pacemaker, Artificial · Cardiac Rhythm Disorder · Bradycardia

Source: ClinicalTrials.gov NCT05252702 ↗

Enrolled (actual)

464

Serious AEs

44.7%

Results posted

Nov 2024

Primary outcomePrimary: Percentage of Participants Free From Aveir DR System-Related Complications at 3-months — 90.3 percentage of participants — p=<0.0001

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Free From Aveir DR System-Related Complications at 3-months	90.3	<0.0001 sig
PRIMARY Percentage of Participants Free From Aveir DR System-Related Complications at 12-months	88.6	<0.0001 sig
PRIMARY Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months	90.8	<0.0001 sig
PRIMARY Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months	92.8	<0.0001 sig
PRIMARY Percentage of Participants With AV Synchrony Success Rate at Rest While Seated	98.2	<0.0001 sig
SECONDARY Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months	91.3	0.0003 sig
SECONDARY Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months	91.0	<0.0001 sig
SECONDARY Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing	0.91	<0.001 sig

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05252702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.