Trials / Completed
CompletedNCT04809701
Non-vascular ICD Electrode Configuration Feasibility Study
Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Temporary implantation of defibrillation coils and pulse generator | Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations. |
| PROCEDURE | Defibrillation following induction of VA (Configuration A first) | Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration A. Then up to two defibrillation energies will be tested for Configuration B. |
| PROCEDURE | Defibrillation following induction of VA (Configuration B first) | Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration B. Then up to two defibrillation energies will be tested for Configuration A. |
| PROCEDURE | Removal of defibrillation coils and pulse generator | Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed. |
Timeline
- Start date
- 2021-03-22
- Primary completion
- 2021-12-07
- Completion
- 2022-03-24
- First posted
- 2021-03-22
- Last updated
- 2022-10-12
Locations
3 sites across 3 countries: Chile, Czechia, Paraguay
Source: ClinicalTrials.gov record NCT04809701. Inclusion in this directory is not an endorsement.