A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter (NCT07116525) | Clinical Trial Compass
RecruitingNot Applicable
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Belgium, France60 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 (\<=) 25 percentage (%) for participants with ventricular arrhythmia
* LVEF \<= 40% for participants with atrial arrhythmia
* Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
* Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)
* History of blood clotting or bleeding abnormalities (example …
What they're measuring
1
Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping
Timeframe: Up to 7 days post index procedure
2
Incidence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping