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NCT07116525
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Conditions: Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Procedures, Ventricular Tachycardia, Ischemic Ventricular Tachycardia, Non-ischemic Ventricular Tachycardia, Cardiomyopathy, Idiopathic Ventricular Tachycardia, Premature Ventricular Contraction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Biosense Webster, Inc.
Location: AZ Sint-Jan Bruges
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 Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause
* Patients requiring left atrial procedures: left atrial size greater than (\>) 55 millimeter (mm)
* Left ventricular ejection fraction(LVEF) less than or equal to (\
Source: ClinicalTrials.gov (NCT07116525). StuddyBuddy aggregates publicly available trial information.