Actively Recruiting
Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter
Led by Biosense Webster, Inc. · Updated on 2026-02-13
60
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of a new paddle-shaped, high-density, multi-electrode mapping catheter designed to map the atrial and ventricular regions of the heart. This study focuses on patients undergoing catheter mapping and ablation procedures to manage various cardiac arrhythmias, including atrial fibrillation, atrial tachycardia, ventricular tachycardia, and premature ventricular contractions. The trial is sponsored by Biosense Webster, Inc. and aims to monitor serious and non-serious adverse events related to the investigational catheter. Participants scheduled for a clinically indicated catheter mapping and ablation procedure will have the procedure performed using the investigational mapping catheter. The catheter is designed to provide detailed mapping of heart arrhythmias to guide the ablation therapy. The study period includes the index procedure and up to seven days of follow-up to assess safety and procedural success. Physicians may use the catheter for endocardial and, if indicated, epicardial mapping during the procedure. During the study, participants will undergo the catheter mapping and ablation procedure, and researchers will evaluate the catheter's deployment, visualization, maneuverability, and signal quality. Safety is monitored by recording any serious or non-serious adverse events within seven days after the procedure. Participants must comply with all pre-, post-, and follow-up testing and requirements, with the total relevant monitoring lasting up to seven days post-procedure.
CONDITIONS
Brief Title
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with and candidate for catheter mapping and ablation procedure for ventricular tachycardia, premature ventricular complex, atrial tachycardia, or atrial fibrillation
- At least one episode of the targeted arrhythmia documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months prior to enrollment
- Age 18 years or older
- Signed informed consent form
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You will not qualify if you...
- Arrhythmia secondary to reversible cause, electrolyte imbalance, thyroid disease, or non-cardiac cause
- Left atrial size greater than 55 millimeters for patients requiring left atrial procedures
- Left ventricular ejection fraction (LVEF) ≤ 25% for ventricular arrhythmia or ≤ 40% for atrial arrhythmia
- Documented intracardiac thrombus within 24 hours prior to catheter insertion
- Contraindication to anticoagulation therapy
- History of blood clotting or bleeding disorders
- Myocardial infarction within past 60 days
- Thromboembolic event within past 12 months
- Uncontrolled heart failure or NYHA class IV
- Recent pacemaker, defibrillator, or appendage closure device implantation within past 42 days
- Known untreatable allergy to contrast media
- Active illness, systemic infection, or sepsis
- Diagnosed cardiac tumors or abnormalities preventing catheter use
- Significant congenital anomaly or medical problem precluding enrollment
- Prior percutaneous or surgical valvular cardiac procedure
- Use of Impella or equivalent devices within 7 days prior to procedure
- Cardiac surgery or percutaneous coronary intervention within past 60 days
- Atrial septal closure within past 42 days
- Conditions preventing vascular access
- Women who are pregnant, lactating, or planning pregnancy during the study
- Vulnerable populations requiring special safeguards
- Concurrent enrollment in another investigational device or drug study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day plus up to 7 days post-procedure
Participants undergo a catheter mapping and ablation procedure using a paddle-shaped, high-density, multi-electrode mapping catheter.
1 procedure visit and follow-up assessments up to 7 days post-procedure
Trial Site Locations
Total: 6 locations
1
AZ Sint-Jan
Bruges, Belgium, 8000
Actively Recruiting
2
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
3
Hopital les Franciscaines of Nimes
Nîmes, France, 30000
Withdrawn
4
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, France, 33600
Actively Recruiting
5
Chu Rennes Hopital Pontchaillou
Rennes, France, 35033
Actively Recruiting
6
Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania, 08406
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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