Extravascular ICD Pivotal Study (EV ICD)
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|ClinicalTrials.gov Identifier: NCT04060680|
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tachycardia Ventricular Arrythmia||Device: Defibrillation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extravascular ICD Pivotal Study (EV ICD)|
|Estimated Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
- Safety Outcome - Freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant [ Time Frame: 6 Months ]Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 6 months post-implant.
- Efficacy Outcome - Defibrillation efficacy at implant of the EV ICD System [ Time Frame: At Implant, up to 2 days ]Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 6 such episodes may be induced to test device efficacy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060680
|Contact: Jo Kruegeremail@example.com|
|Principal Investigator:||Paul Friedman, MD||Mayo Clinic|