At a glance
ClinicalIndex Comparison RecordN/ACompleted· 167 enrolled
Drug / intervention
RELIANCE 4-FRONT™ Passive Fixation lead implantationdevice
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.
RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
In Brief
A clinical study evaluating RELIANCE 4-FRONT™ Passive Fixation lead implantation for Tachycardia and 2 related conditions. Completed, enrolled 167 participants across 11 sites in 3 countries.
Detailed Summary
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTachycardia, Ventricular Fibrillation, Ventricular Flutter
CountriesGermany, Israel, Italy
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartDec 2013
Primary CompletionNov 2015
Study CompletionNov 2017
TodayJul 2026
First PostedMay 17, 2013
Enrollment StartDec 16, 2013
Primary CompletionNov 2, 2015
Study CompletionNov 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.1 years ago
Interventions
RELIANCE 4-FRONT™ Passive Fixation lead implantationdevice
Implantation of transvenous defibrillation lead with passive fixation mechanism.