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 States952 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 range18 Years
SexALL
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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.
Exclusion criteria
✕. 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
What they're measuring
1
Complication-Free Rate
Timeframe: 6 months
2
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range