Fact CheckerSign in

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.
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AZ Sint Jan
Coordinator of this site? Confirm its status
BrugesBelgiumRecruiting
JESSA Ziekenhuis
Coordinator of this site? Confirm its status
HasseltBelgiumRecruiting
CHU de Bordeaux - Hospital Haut-Leveque
Coordinator of this site? Confirm its status
PessacFranceRecruiting
CHU Rennes - Hopital Pontchaillou
Coordinator of this site? Confirm its status
RennesFranceRecruiting
Vilnius University Hospital Santaros Clinics
Coordinator of this site? Confirm its status
VilniusLithuaniaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.