Trials / Completed
CompletedNCT05181878
AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 8 (actual)
- Sponsor
- Acutus Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
Non-Significant Risk Clinical Study Clinical Investigational Use Only for the purposes of collecting electromagnetic tracking data to validate the use of the device in a clinical setting.
Detailed description
The EMT Feasibility Study is a prospective, multi-center, feasibility study designed to demonstrate the feasibility of EMT solution in conjunction with the AcQMap 2.1 System's existing capabilities. The objective of the study is to demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The AcQMap 2.1 System with Electro-Magnetic Tracking Feasibility System | Demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position. |
Timeline
- Start date
- 2021-12-29
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2022-01-06
- Last updated
- 2023-11-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05181878. Inclusion in this directory is not an endorsement.