Actively Recruiting
Evaluation of a Paddle-Shaped, High-Density Multi-Electrode Catheter for Mapping and Treating Heart Rhythm Disorders
Led by Biosense Webster, Inc. · Updated on 2026-07-31
90
Participants Needed
6
Research Sites
18 weeks
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 in patients with various arrhythmias. This device is studied in individuals undergoing clinically indicated catheter mapping and ablation procedures for managing arrhythmias such as ventricular tachycardia, atrial fibrillation, and premature ventricular contractions. Participants will undergo catheter mapping and ablation using the investigational multi-electrode mapping catheter during their scheduled procedures. The catheter is used to perform high-density mapping of the hearts electrical activity to guide treatment. The study focuses on the devices safety, including serious adverse events within 7 days post-procedure, and its ability to complete all required pre-ablation mapping tasks. Evaluation includes physician assessments of the catheters deployment, maneuverability, and signal quality. During the study, participants will be monitored for safety outcomes up to 7 days after the procedure. Researchers will collect data on adverse events, mapping completion, and device performance. Participants must comply with all pre-procedure, post-procedure, and follow-up testing and requirements. The studys total duration includes the procedure day and a 7-day follow-up period to assess device-related safety and effectiveness parameters.
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 ventricular tachycardia, premature ventricular complex, atrial tachycardia, or atrial fibrillation and scheduled for catheter mapping and ablation
- At least one episode of targeted arrhythmia documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months
- 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 caused by reversible factors or non-cardiac causes like electrolyte imbalance or thyroid disease
- Left atrial size greater than 55 mm for patients needing left atrial procedures
- Left ventricular ejection fraction (LVEF) ≤ 25% for ventricular arrhythmia or ≤ 40% for atrial arrhythmia
- Presence of intracardiac thrombus detected within 24 hours prior to catheter insertion
- Contraindication to anticoagulation medications such as heparin, warfarin, or dabigatran
- History of blood clotting or bleeding disorders
- Myocardial infarction within the past 60 days
- Thromboembolic event within the past 365 days
- Uncontrolled heart failure or NYHA class IV
- Recent pacemaker, defibrillator, or appendage closure device implantation within 42 days
- Known untreatable allergy to contrast media
- Active infection or systemic illness
- Cardiac abnormalities precluding catheter use
- Significant congenital anomaly or medical condition preventing enrollment
- Previous valvular cardiac surgery or prosthetic valve presence
- Use of Impella or equivalent devices within 7 days prior to procedure
- Cardiac surgery or PCI within past 60 days
- Atrial septal closure within past 42 days
- Conditions preventing vascular access
- Pregnancy, lactation, or plans for pregnancy during the study
- Vulnerable populations requiring special safeguards
- Concurrent enrollment in another investigational device or drug study
Research Team
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Study Contact
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