Active — Not RecruitingNot Applicable

Aveir DR i2i Study

United States464 participantsStarted 2022-02-02

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: 3 months

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

Timeframe: 12 months

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

Timeframe: 3 months

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

Timeframe: 12 months

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

Timeframe: 3 months

Trial details

NCT IDNCT05252702

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-02

Results submitted2024-08-01

View on ClinicalTrials.gov More Cardiac Pacemaker, Artificial trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: 3 months

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

Timeframe: 12 months

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

Timeframe: 3 months

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

Timeframe: 12 months

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

Timeframe: 3 months