Clinical Evaluation of Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Status: Completed
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)

• At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment

• Signed participants Informed Consent Form (ICF)

• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Locations
Other Locations
Belgium
Onze-Lieve-Vrouw (OLV) Ziekenhuis
Aalst
Universitair Ziekenhuis (UZ) Brussel
Brussels
Croatia
University Hospital Center Split
Split
Italy
Ospedale Generale Regionale Francesco Miulli (F. Miulli)
Acquaviva Delle Fonti
Time Frame
Start Date: 2022-07-29
Completion Date: 2023-02-20
Participants
Target number of participants: 40
Treatments
Experimental: Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Participants with cardiac arrhythmias/ablation history who are scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures will be using multi-electrode mapping catheter.
Sponsors
Leads: Biosense Webster, Inc.

This content was sourced from clinicaltrials.gov