A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter

Official title

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

Overview

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.

Interventions

• Device Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
  High-density, multi-electrode mapping catheter will be used for the procedure.

Primary outcome measures

• Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping [Time frame: Up to 7 days post index procedure]
• Incidence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping [Time frame: Up to 7 days post index procedure]

Secondary outcome measures (5)

• Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality [Time frame: Up to 7 days post index procedure]
• Incidence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion [Time frame: Up to 7 days post index procedure]
• Incidence of all Other SAEs Not Related to the Investigational Catheter [Time frame: Up to 7 days post index procedure]
• Incidence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter [Time frame: Up to 7 days post index procedure]
• Incidence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion [Time frame: Up to 7 days post index procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

France · 3 centers

• Hopital les Franciscaines of Nimes — Nîmes
• CHU de Bordeaux - Hospital Haut-Leveque — Pessac
• Chu Rennes Hopital Pontchaillou — Rennes

Belgium · 2 centers

• AZ Sint-Jan — Bruges
• Jessa Ziekenhuis — Hasselt

Lithuania · 1 center

• Vilnius University Hospital Santaros Clinics — Vilnius

Identifiers

NCT: NCT07116525 · BWI202307 · BWI202307

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗