Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CLP-24 (EU) | Other Identifier | Acutus Medical, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The AcQMap 2.1 System with Electro-Magnetic Tracking Feasibility System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful recording of continuous and synchronized impedance and magnetic localization information. | Successful recording of continuous and synchronized impedance and magnetic localization information. | Procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap 2.1 System.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | United States | ||
| Nevada Heart and Vascular |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Las Vegas |
| Nevada |
| 89118 |
| United States |