Testing a New Heart Mapping Catheter in People With Irregular Heartbeats
Tests a new paddle-shaped catheter for mapping heart rhythm problems in adults with arrhythmias.
Key facts
- Who runs it
- Biosense Webster, Inc.
- Where
- Vilnius, LithuaniaSee the siteAlso in 2 other countries, 4 sites
- Trial code
- Registry title
- A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
- Status
- Recruiting
- People taking part
- 90 people, planned
- Started
- 15 Sept 2025
- Expected to end
- 7 Feb 2027
- Type of study
- Interventional
- Treatments tested
- Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are already planned for a heart rhythm mapping and ablation procedure for ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Diagnosed with ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation, and a candidate for catheter mapping and ablation. At least one episode was documented within 12 months before enrollment.
- Earlier treatment
- A previous ablation procedure is allowed. People who ever had a heart valve procedure (including a prosthetic valve), cardiac surgery or PCI within the past 60 days, or an Impella-type device cannot join.
Main reasons for not taking part
- Heart rhythm problem caused by a reversible cause, electrolyte imbalance, thyroid disease or a non-cardiac cause
- Left ventricular ejection fraction of 25% or less (ventricular arrhythmia) or 40% or less (atrial arrhythmia)
- Heart attack within the past 60 days, or a thromboembolic event (including TIA) within the past 365 days
- Cannot take anticoagulation, or has clotting or bleeding problems, or a clot inside the heart
- Pregnant, breastfeeding, or planning pregnancy during the study
The registry criteria, word for word
Show all 28 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Left ventricular ejection fraction(LVEF) less than or equal to (<=) 25 percentage (%) for participants with ventricular arrhythmia
- LVEF <= 40% for participants with atrial arrhythmia
- 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
- 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)
Where in Lithuania
Also in 2 other countries, 4 sites
- Vilnius University Hospital Santaros ClinicsVilnius, LithuaniaTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping CatheterTreatment being tested
Participants scheduled to have a clinically indicated mapping and ablation procedure for the management of cardiac arrhythmias. The investigational paddle-shaped, high-density, multi-electrode catheter is used for mapping purposes only.
Treatment: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)
- Plain-language title
- Testing a New Heart Mapping Catheter in People With Irregular HeartbeatsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 November 2026