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NCT04060680 · ClinicalTrials.gov registry record · NA
Extravascular ICD Pivotal Study
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 393
- Enrollment target
NCT04060680: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT04060680 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 393 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04060680, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 393 participants
- Enrollment target
Study 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.
Primary Outcome
The primary safety endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 6 months (182 days) post-implant.
Interventions
- DEVICE Defibrillation using the Extravascular ICD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2024-01-04 |
| Phase | NA |
What the finished NCT04060680 record still lists
NCT04060680 is an interventional study that assigns participants to a tested intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Defibrillation using the Extravascular ICD is the first listed.
NCT04060680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04060680 about?
NCT04060680 is a clinical study titled "Extravascular ICD Pivotal Study". 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) ...
What is the current status of trial NCT04060680?
This trial is currently completed. It is a NA study. The enrollment target is 393 participants. The study started on 2019-09-16. Estimated completion is 2024-01-04.
What interventions are being tested in trial NCT04060680?
The interventions under investigation include: Defibrillation using the Extravascular ICD (DEVICE).
Who is sponsoring clinical trial NCT04060680?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04060680's enrollment target sits among peer trials
393 269th of 2000 higher than 1,732 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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