Trials / Completed
CompletedNCT03608670
Extravascular ICD Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.
Detailed description
The study will recruit male and female adult subjects that meet all of the inclusion criteria and none of the exclusion criteria. All subjects will be indicated to receive an ICD. The EV ICD system will be implanted and the subjects will be followed for at least 3 months following implantation of the system. Subjects will be exited after follow-up is completed.
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
- 2018-07-17
- Primary completion
- 2019-03-11
- Completion
- 2023-11-15
- First posted
- 2018-08-01
- Last updated
- 2024-01-08
- Results posted
- 2022-04-22
Locations
4 sites across 2 countries: Australia, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03608670. Inclusion in this directory is not an endorsement.