The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker (NCT02030418) | Clinical Trial Compass
CompletedNot Applicable
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
United States, Australia, Canada952 participantsStarted 2014-02
Plain-language summary
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.
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 one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:
. Subject ≥18 years of age; and
. Subject has life expectancy of at least one year; and
. Subject is not enrolled in another clinical investigation; and
. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB; and
. Subject is not pregnant and does not plan to get pregnant during the course of the study.
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
1
Complication-Free Rate
Timeframe: 6 months
2
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
. Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
. Subject is allergic or hypersensitive to \<1 mg of dexamethasone sodium phosphate; or
. Subject has a mechanical tricuspid valve prosthesis; or
. Subject has a pre-existing endocardial pacing or defibrillation leads; or
. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
. Subject has an implanted vena cava filter; or
. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
. Subject has an implanted leadless cardiac pacemaker; or