Actively Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Led by Biosense Webster, Inc. · Updated on 2026-02-13
60
Participants Needed
6
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 clinically indicated 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 Patient Informed Consent Form (ICF)
- 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) less than or equal to 25% for ventricular arrhythmia patients
- LVEF less than or equal to 40% for atrial arrhythmia patients
- Documented intracardiac thrombus within 24 hours prior to catheter insertion
- Contraindication to anticoagulation medications
- History of blood clotting or bleeding abnormalities
- Myocardial infarction within the past 60 days
- Thromboembolic event within the past 12 months
- Uncontrolled heart failure or NYHA class IV
- Implanted pacemaker, intracardiac defibrillator, or appendage closure device within past 42 days
- Known untreatable allergy to contrast media
- Active illness, systemic infection, or sepsis
- Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor, or other abnormalities preventing catheter use
- Significant congenital anomaly or medical problem precluding enrollment
- Previous percutaneous or surgical valvular cardiac procedure
- Current or recent use of Impella or equivalent devices
- Cardiac surgery within past 60 days including PCI
- Atrial septal closure within past 42 days
- Condition 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
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
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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