Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.

Biosense Webster, Inc.98 enrolled

Overview

This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.

The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Radiofrequency AblationDEVICE

RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with Symptomatic Paroxysmal AF. 2. Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation. 3. Able and willing to comply with uninterrupted per-protocol anticoagulation requirements 4. Age 18-75 years. 5. Able and willing to comply with all pre-, post- and follow-up testing and requirements. 6. Signed Patient Informed Consent Form. Exclusion Criteria: 1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 2. Previous surgical or catheter ablation for AF. 3. Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region 4. Previously diagnosed with persistent, longstanding AF and/or continuous AF \> 7 days, or \> 48 hrs terminated by cardioversion. 5. Any percutaneous coronary intervention (PCI) within the past 2 months. 6. Valve repair or replacement and presence of a prosthetic valve. 7. Any carotid stenting or endarterectomy. 8. Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months. 9. Documented left atrium (LA) thrombus on baseline/pre-procedure imaging. 10. LA antero posterior diameter \> 50 mm 11. Any PV with a diameter ≥ 26 mm 12. Left Ventricular Ejection Fraction (LVEF) \< 40%. 13. Contraindication to anticoagulation (e.g. heparin). 14. History of blood clotting or bleeding abnormalities. 15. Myocardial infarction within the past 2 months. 16. Documented thromboembolic event \[including transient ischemic attack(TIA)\] within the past 12 months. 17. Rheumatic Heart Disease. 18. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV. 19. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months. 20. Unstable angina. 21. Acute illness or active systemic infection or sepsis. 22. Diagnosed atrial myxoma or interatrial baffle or patch. 23. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD). 24. 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. 25. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study. 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 an Inferior Vena Cava (IVC) filter 31. Presence of a condition that precludes vascular access. 32. Life expectancy or other disease processes likely to limit survival to less than 12 months. 33. Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use. 34. Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects: 35. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion) 36. Presence of iron-containing metal fragments in the body 37. Unresolved pre-existing neurological deficit.

Locations (5)

Na Homolce Hospital

Prague, Czechia

Ospedale "F. Miulli"

Bari, Italy

Centro Cardiologico Monzino

Milan, Italy

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Bart's Health NHS Trust

Outcomes

Primary Outcomes

Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis

A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

Time frame: Up to 90 days (post initial mapping and ablation procedure)

Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Time frame: Up to 7 days (post initial mapping and ablation procedure)

Percentage of Participants With Acute Procedural Success

Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

Time frame: Day 1

Secondary Outcomes

Number of Participants With Individual PAE From Primary Composite

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Data from ClinicalTrials.gov

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