Trials / Completed
CompletedNCT04983797
A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
Clinical Evaluation of Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (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 OPTRELL Catheter for intracardiac mapping in the atria and ventricles.
Conditions
- Scar-related Atrial Tachycardia
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
- Tachycardia, Ventricular
- Ventricular Premature Complexes
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OPTRELL Mapping Catheter | Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the 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
- 2021-08-25
- Primary completion
- 2021-11-04
- Completion
- 2021-11-04
- First posted
- 2021-07-30
- Last updated
- 2023-07-03
- Results posted
- 2023-01-19
Locations
3 sites across 2 countries: Belgium, Lithuania
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04983797. Inclusion in this directory is not an endorsement.