Scar-related Atrial TachycardiaFEATHERNCT07116525
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
A study testing Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter in people with Scar-related Atrial Tachycardia and Persistent Atrial Fibrillation, run by Biosense Webster, Inc. at 5 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 Sep 2025to 7 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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)
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- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Belgium2 sites, 2 recruiting
- Recruiting
AZ Sint-Jan
Bruges, 8000
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
France2 sites, 2 recruiting
- Recruiting
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604
- Recruiting
Chu Rennes Hopital Pontchaillou
Rennes, 35033
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Clinics
Vilnius, 08406
About this study
Official title: Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)
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.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia, Ischemic Ventricular Tachycardia, Non-ischemic Ventricular Tachycardia
- Being tested
- Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Ventricular, Cardiomyopathies, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paddle-Shaped, High-Density, Multi-Electrode Mapping CatheterDevice
High-density, multi-electrode mapping catheter will be used for the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping Catheter | Experimental | 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. Receives: Device: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping
A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Measured: Up to 7 days post index procedure
Occurrence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping
Occurrence of all pre-ablation endocardial mapping requirements and any clinically indicated endocardial mapping with the investigational catheter, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.
Measured: Up to 7 days post index procedure
Secondary outcomes (5)
Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality
Physician feedback on the catheter deployment, visualization, maneuverability, and signal quality acquired with the investigational catheter for mapping of the atria and ventricles, inclusive of endocardial and epicardial spaces, using a physician-completed survey, using a Likert scale of 1 to 7 (1=poor and 7=excellent) will be summarized.
Measured: Up to 7 days post index procedure
Occurrence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion
A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Measured: Up to 7 days post index procedure
Occurrence of all Other SAEs Not Related to the Investigational Catheter
Occurrence of all other SAEs not related to the investigational catheter will be reported.
Measured: Up to 7 days post index procedure
Occurrence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter
Occurrence of non-serious AEs related to the investigational catheter will be reported.
Measured: Up to 7 days post index procedure
Occurrence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion
Occurrence of completion with all pre-ablation epicardial mapping requirements and any clinically indicated epicardial mapping with the investigational catheter as per physician's discretion, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.
Measured: Up to 7 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion7 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar-related Atrial TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biosense Webster, Inc. Clinical Trial, Study director, Biosense Webster, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116525
- Sponsor's protocol ID
- BWI202307
- Acronym
- FEATHER
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson MedTech is available at https://www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu