Trials / Completed
CompletedNCT02941250
Acute Defibrillation Performance of a Novel Can-less Shock Pathway
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- NewPace Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.
Detailed description
The purpose of this study is to evaluate the operation, safety, and feasibility of the ISSD system in patients who require an ICD. An ISSD emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, and then entirely removed. The emulator is not a powered medical device. This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ISSD emulator | induced tachy-arrhythmia to be terminated by ISSD emulator |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-04-01
- Completion
- 2017-04-01
- First posted
- 2016-10-21
- Last updated
- 2017-09-15
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT02941250. Inclusion in this directory is not an endorsement.