Early feasibility first-in-human study using a novel radiofrequency ablation catheter

Not Applicable

Completed

• Conditions: Drug refractory symptomatic paroxysmal atrial fibrillation; Circulatory System

• Registration Number: ISRCTN11764506
• Lead Sponsor: Biosense Webster, Inc.

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31826648 (added 13/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-30
• Study Completion: 2017-06-30
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

1. Symptomatic paroxysmal atrial fibrillation with at least one documented atrial fibrillation episode within one year prior to enrollment
2. Failed at least one antiarrhythmic drug (class I or III)
3. Pre-procedural anticoagulation on warfarin, rivaroxaban or apixaban. If receiving warfarin therapy, patients must agree to take warfarin for at least 4 weeks prior to the scheduled ablation procedure.
4. Age 18 years or older
5. Able and willing to comply with all pre-, post- and follow-up testing and requirements (e.g. Patient not confined by a court ruling)
6. Signed Patient Informed Consent Form

Exclusion Criteria

1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
2. Previous surgical or catheter ablation for atrial fibrillation
3. Previously diagnosed with persistent or longstanding atrial fibrillation
4. Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g. ventriculotomy, atriotomy) within the past 2 months
5. Valve repair or replacement and presence of a prosthetic valve
6. Any carotid stenting or endarterectomy
7. Coronary artery bypass grafting surgery within the past 6 months
8. Documented left atrium thrombus on baseline/pre-procedure imaging
9. LA size > 55 mm
10. Left Ventricular Ejection Fraction (LVEF) < 40%
11. Contraindication to anticoagulation (heparin or warfarin)
12. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc.
13. History of blood clotting or bleeding abnormalities
14. Myocardial infarction within the past 2 months
15. Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months
16. Rheumatic Heart Disease
17. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
18. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
19. Unstable angina
20. Acute illness or active systemic infection or sepsis
21. Diagnosed atrial myxoma
22. Presence of implanted pacemaker, implantable cardioverter defibrillator (ICD), or tissue-embedded, iron-containing metal fragments
23. Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
24. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study
25. Unresolved pre-existing neurological deficit
26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation
27. Enrollment in an investigational study evaluating another device, biologic, or drug
28. Has known pulmonary vein stenosis
29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
30. Presence of a condition that precludes vascular access
31. Life expectancy or other disease processes likely to limit survival to less than 12 months
32. Presenting contra-indication for the devices (e.g. esophageal endoscope, CT, etc.) used in the study, as indicated in the respective instructions for use
33. Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified