Trials / Unknown
UnknownNCT05214170
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- NeuTrace, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
Detailed description
Arrhythmias, or abnormal heart rhythms, are a major cause of morbidity and mortality worldwide. In patients with arrhythmias, electrophysiology (EP) studies are often performed to assess the electrical system of the heart. Since its introduction in the 1990s, electroanatomic mapping has become a cornerstone of EP studies. Electroanatomic mapping systems allow for non-fluoroscopic navigation of the heart and the creation of three-dimensional (3D) anatomic and electroanatomic maps. These maps facilitate diagnosing and treating arrhythmias. The NeuTrace System is a cardiac EP mapping system that is intended to be used during catheter-based atrial and ventricular mapping procedures. The system is designed to acquire and analyze data points and use this information to display 3D anatomical and electroanatomic mapping of the human heart. The system is used with a compatible, marketed magnetic sensor-enabled catheter and compatible EP recording system to acquire the location information and local electrogram needed to create the cardiac maps. The purpose of the trial is to evaluate physician acceptance and feasibility of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Electroanatomic mapping with the NeuTrace System | Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System. |
Timeline
- Start date
- 2021-06-07
- Primary completion
- 2024-05-07
- Completion
- 2024-06-07
- First posted
- 2022-01-28
- Last updated
- 2023-04-07
Locations
1 site across 1 country: Lithuania
Source: ClinicalTrials.gov record NCT05214170. Inclusion in this directory is not an endorsement.