CompletedNot Applicable

Aveir DR i2i Study

United States, Austria, Belgium464 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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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

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