A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
NCT ID: NCT07116525
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-09-15
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping Catheter
Participants scheduled to have a clinically indicated catheter mapping and ablation procedure for management of a cardiac arrhythmias will undergo catheter mapping and ablation procedure using paddle-shaped, high-density, multi-electrode mapping catheter.
Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
High-density, multi-electrode mapping catheter will be used for the procedure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
High-density, multi-electrode mapping catheter will be used for the procedure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biosense Webster, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Biosense Webster, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Biosense Webster, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AZ Sint-Jan
Bruges, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Hopital les Franciscaines of Nimes
Nîmes, , France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, , France
Chu Rennes Hopital Pontchaillou
Rennes, , France
Vilnius University Hospital Santaros Clinics
Vilnius, , Lithuania
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BWI202307
Identifier Type: OTHER
Identifier Source: secondary_id
BWI202307
Identifier Type: -
Identifier Source: org_study_id