Arrhythmia mapping with a paddle-shaped multi-electrode catheter

Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter

This test uses a new high-density multi-electrode catheter to see if it can safely map atrial and ventricular arrhythmias in adults having catheter mapping and ablation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biosense Webster, Inc. (industry)
• Locations: 6 sites (Bruges and 5 other locations)
• Trial ID: NCT07116525 on ClinicalTrials.gov

What this trial studies

Adults with atrial or ventricular arrhythmias who are scheduled for clinically indicated catheter mapping and ablation will have the investigational paddle-shaped, high-density multi-electrode catheter used during their procedure to create electrical maps of the heart. The study will record whether the catheter can produce usable maps (feasibility) and capture any device- or procedure-related adverse events (safety). Eligible participants must have had a documented episode of the target arrhythmia within the prior 12 months and be able to consent and complete follow-up. Patients with arrhythmias due to reversible causes or those requiring left atrial procedures are excluded.

Who should consider this trial

Good fit: Adults (18+) scheduled for clinically indicated catheter mapping and ablation for ventricular tachycardia, premature ventricular complexes, atrial tachycardia, or atrial fibrillation with documentation of the arrhythmia within the past 12 months are ideal candidates.

Not a fit: Patients whose arrhythmias are caused by reversible noncardiac factors or electrolyte/thyroid imbalance, and those who require left atrial-specific procedures, are unlikely to benefit from this mapping device.

Why it matters

Potential benefit: If successful, the catheter could provide faster and more detailed electrical maps to better guide ablation and potentially improve procedural success and safety.

How similar studies have performed: Other high-density multi-electrode mapping systems have been used successfully to produce detailed cardiac maps and speed mapping, though the specific paddle-shaped catheter design under test is a newer configuration.

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

Where this trial is running

Bruges and 5 other locations

• AZ Sint-Jan — Bruges, Belgium (RECRUITING)
• Jessa Ziekenhuis — Hasselt, Belgium (RECRUITING)
• Hopital les Franciscaines of Nimes — Nîmes, France (WITHDRAWN)
• CHU de Bordeaux - Hospital Haut-Leveque — Pessac, France (RECRUITING)
• Chu Rennes Hopital Pontchaillou — Rennes, France (RECRUITING)
• Vilnius University Hospital Santaros Clinics — Vilnius, Lithuania (RECRUITING)

Study contacts

• Study coordinator: Study Contact

Conditions: Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Procedures, Ventricular Tachycardia, Ischemic Ventricular Tachycardia, Non-ischemic Ventricular Tachycardia, Cardiomyopathy