At a glance
ClinicalIndex Comparison RecordN/ACompleted· 393 enrolled
Drug / intervention
Defibrillation using the Extravascular ICDdevice
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.
Extravascular ICD Pivotal Study (EV ICD)
In Brief
A clinical study evaluating Defibrillation using the Extravascular ICD for Tachycardia and Ventricular Arrythmia. Completed, enrolled 393 participants across 56 sites in 17 countries.
Detailed Summary
Pivotal Summary: The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System. Continued Access Summary: This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTachycardia, Ventricular Arrythmia
CountriesAustralia, Austria, Canada, Denmark, France, Hong Kong, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartSep 2019
Primary CompletionApr 2022
Study CompletionJan 2024
TodayJul 2026
First PostedAug 19, 2019
Enrollment StartSep 16, 2019
Primary CompletionApr 28, 2022
Study CompletionJan 4, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.9 years ago
Interventions
Defibrillation using the Extravascular ICDdevice
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.