Trials / Withdrawn
WithdrawnNCT05049720
ExtraVascular Implantable Cardiac Defibrillator Continued Access Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
Detailed description
The study will enroll subjects who are indicated to receive an implantable defibrillator who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed every 6 months following system implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Defibrillation using the Extravascular ICD | VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing. |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2023-07-28
- Completion
- 2023-07-28
- First posted
- 2021-09-20
- Last updated
- 2022-09-10
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05049720. Inclusion in this directory is not an endorsement.