At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,060 enrolled
Drug / intervention
INGEVITY leaddevice
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.
INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
In Brief
A clinical study evaluating INGEVITY lead for Bradycardia and Sinus Node Dysfunction. Completed, enrolled 1,060 participants across 78 sites in 16 countries.
Detailed Summary
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia, Sinus Node Dysfunction
CountriesAustralia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Malaysia, Portugal, Spain, Sweden, Thailand, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartOct 2012
Primary CompletionJan 2015
Study CompletionFeb 2019
TodayJul 2026
First PostedSep 20, 2012
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2015
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.8 years ago
Interventions
INGEVITY leaddevice