Study utilizing a novel mapping catheter in heart arrhythmias

Not Applicable

Completed

• Conditions: Ventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation; Circulatory System

• Registration Number: ISRCTN93591221
• Lead Sponsor: Biosense Webster, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-02
• Study Completion: 2019-02-08
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

1. History of continuous atrial fibrillation (AF) sustained longer than 12 months
2. History of AF <7 days and no previous AF ablation procedure
3. Previously diagnosed with long-standing persistent atrial fibrillation
4. Previously diagnosed with idiopathic PVC/VT
5. Study arrhythmia secondary to reversible cause
6. Atrial arrhythmias: patients with a left atrial size >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
Deployment, use, and mapping of the novel mapping catheter in the atria and ventricles during the study procedure, characterised with descriptive statistics.