NCT07116525Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 6 Aug 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 7 Feb 2027
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07116525
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 15 Sept 2025 to the primary completion date, 7 Feb 2027
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
- Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior
- 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
Other illness
- Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause
- History of blood clotting or bleeding abnormalities (example hypercoagulable state)
- Myocardial infarction within the past 2 months (60 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
- 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)
- Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention \[PCI\])
- Presence of a condition that precludes vascular access
Lab values
- Left ventricular ejection fraction(LVEF) less than or equal to (\<=) 25 percentage (%) for participants with ventricular arrhythmia
- LVEF \<= 40% for participants with atrial arrhythmia
Age
- 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
Other
- Patients requiring left atrial procedures: left atrial size greater than (\>) 55 millimeter (mm)
- Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)
- Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months (365 days)
- 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
- Atrial septal closure within the past 6 weeks (42 days)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| CHU de Bordeaux - Hospital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| CHU Rennes - Hopital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Vilnius University Hospital Santaros Clinics Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.