Trials / Completed
CompletedNCT05373862
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Clinical Evaluation of Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
Conditions
- Scar-related Atrial Tachycardia
- Persistent Atrial Fibrillation
- Paroxysmal Atrial Fibrillation
- Ventricular Tachycardia
- Premature Ventricular Complex
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter | Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for management of atrial procedure (scar-related atrial tachycardia, persistent atrial fibrillation, paroxysmal atrial fibrillation) and Ventricular procedures (ventricular tachycardia, premature ventricular complex). |
Timeline
- Start date
- 2022-07-29
- Primary completion
- 2023-02-20
- Completion
- 2023-02-20
- First posted
- 2022-05-13
- Last updated
- 2025-03-03
- Results posted
- 2024-03-13
Locations
4 sites across 3 countries: Belgium, Croatia, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05373862. Inclusion in this directory is not an endorsement.