NCT07116525 A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
| NCT ID | NCT07116525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biosense Webster, Inc. |
| Condition | Scar-related Atrial Tachycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-09-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 (\<=) 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 hypercoagulable state) * Myocardial infarction within the past 2 months (60 days) * Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months (365 days) * Uncontrolled heart failure or New York heart association (NYHA) function class IV * Implanted with a pacemaker or intracardiac cardiac defibrillator or appendage closure device within the past 6 weeks (42 days) * Patients with known untreatable allergy to contrast media * Active illness or active systemic infection or sepsis * Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) * Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior * Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention \[PCI\]) * Atrial septal closure within the past 6 weeks (42 days) * Presence of a condition that precludes vascular access * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being * Concurrent enrollment in an investigational study evaluating another device or drug
Contact & Investigator
Biosense Webster, Inc. Clinical Trial
STUDY DIRECTOR
Biosense Webster, Inc.
Frequently Asked Questions
Who can join the NCT07116525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scar-related Atrial Tachycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116525 currently recruiting?
Yes, NCT07116525 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07116525 trial being conducted?
This trial is being conducted at Bruges, Belgium, Hasselt, Belgium, Pessac, France, Rennes, France and 1 additional location.
Who is sponsoring the NCT07116525 clinical trial?
NCT07116525 is sponsored by Biosense Webster, Inc.. The principal investigator is Biosense Webster, Inc. Clinical Trial at Biosense Webster, Inc.. The trial plans to enroll 90 participants.