Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.

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 (participant 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 prior to enrollment

• Age 18 years or older

• Signed Patient Informed Consent Form (ICF)

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

Locations
Other Locations
Belgium
AZ Sint-Jan
RECRUITING
Bruges
Jessa Ziekenhuis
RECRUITING
Hasselt
France
Hopital les Franciscaines of Nimes
NOT_YET_RECRUITING
Nîmes
CHU de Bordeaux - Hospital Haut-Leveque
RECRUITING
Pessac
Chu Rennes Hopital Pontchaillou
NOT_YET_RECRUITING
Rennes
Lithuania
Vilnius University Hospital Santaros Clinics
NOT_YET_RECRUITING
Vilnius
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
Experimental: Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping Catheter
Participants scheduled to have a clinically indicated catheter mapping and ablation procedure for management of a cardiac arrhythmias will undergo catheter mapping and ablation procedure using paddle-shaped, high-density, multi-electrode mapping catheter.
Sponsors
Leads: Biosense Webster, Inc.

This content was sourced from clinicaltrials.gov