Extravascular ICD Pivotal Study (EV ICD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04060680|
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tachycardia Ventricular Arrythmia||Device: Defibrillation using the Extravascular ICD||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)|
|Actual Study Start Date :||September 16, 2019|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2023|
Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.
Device: Defibrillation using the Extravascular ICD
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: Dawn Dyer||(954)email@example.com|
|Principal Investigator:||Paul Friedman, MD||Mayo Clinic|