At a glance
ClinicalIndex Comparison RecordN/ACompleted· 952 enrolled
Drug / intervention
Leadless Pacemakerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
In Brief
A clinical study evaluating Leadless Pacemaker for Bradycardia. Completed, enrolled 952 participants across 59 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia
CountriesAustralia, Canada, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartFeb 2014
Primary CompletionJun 2015
Study CompletionJul 2022
TodayJul 2026
First PostedJan 8, 2014
Enrollment StartFeb 1, 2014
Primary CompletionJun 1, 2015
Study CompletionJul 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.5 years ago
Interventions
Leadless Pacemakerdevice
Patients will undergo an attempted leadless pacemaker implant