Ventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation Circulatory System Ventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation
Conditions
Interventions
The novel diagnostic mapping catheter will be used by doctors to better understand areas of the heart that initiate or sustain irregular heart rhythms (“cardiac arrhythmias”). The patient will have th
Sponsors
Biosense Webster, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with and is a candidate for clinically-indicated catheter ablation procedure for the management of: 1.1. Ischemic ventricular tachycardia 1.2. Atrial tachycardia/atypical atrial flutter/paroxysmal atrial fibrillation following a pulmonary vein isolation ablation or mitral valve repair procedure 1.3. Persistent atrial fibrillation 2. Aged 18 years or older 3. Able to provide informed consent 4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
Exclusion criteria: 1. History of continuous atrial fibrillation (AF) sustained longer than 12 months 2. History of AF 55 mm 7. LVEF = 25% for VT patients 8. LVEF = 40% for AF patients 9. Documented thrombus in the chamber to be mapped by the study catheter on imaging 10. Contraindication to anticoagulation (i.e. heparin, warfarin, dabigatran) 11. History of blood clotting or bleeding abnormalities (e.g. hypercoagulable state) 12. Myocardial infarction within the past 2 months (60 days) 13. Documented thromboembolic event (including TIA) within the past 12 months (365 days) 14. Uncontrolled heart failure or NYHA function class III or IV 15. Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 3 months (90 days) 16. Implanted with a prosthetic valve 17. Active systemic infection 18. Diagnosed atrial or ventricular myxoma 19. Implanted with an interatrial baffle or patch 20. Atrial septal closure within the past 6 weeks (42 days) 21. Presence of a condition that precludes vascular access 22. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation 23. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 24. Enrollment in an investigational study evaluating another device or drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Completion of pre-ablation mapping and clinically indicated mapping with the novel mapping catheter without resort to using a nonstudy mapping catheter, assessed during the patient's procedure. 2. Incidence of serious adverse events, self-reported by patients and assessed from the time of enrolment through to the 7 day follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Deployment, use, and mapping of the novel mapping catheter in the atria and ventricles during the study procedure, characterised with descriptive statistics. | — |
Countries
Belgium, United Kingdom
Contacts
Public ContactNathalie Macours
Outcome results
None listed