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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Symptomatic Paroxysmal AF. Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation. Able and willing to comply with uninterrupted per-protocol anticoagulation requirements Age 18-75 years. Able and willing to comply with all pre-, post- and follow-up testing and requirements. Signed Patient Informed Consent Form. Exclusion Criteria: AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. Previous surgical or catheter ablation for AF. Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion. Any percutaneous coronary intervention (PCI) within the past 2 months. Valve repair or replacement and presence of a prosthetic valve. Any carotid stenting or endarterectomy. Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months. Documented left atrium (LA) thrombus on baseline/pre-procedure imaging. LA antero posterior diameter > 50 mm Any PV with a diameter ≥ 26 mm Left Ventricular Ejection Fraction (LVEF) < 40%. Contraindication to anticoagulation (e.g. heparin). History of blood clotting or bleeding abnormalities. Myocardial infarction within the past 2 months. Documented thromboembolic event [including transient ischemic attack(TIA)] within the past 12 months. Rheumatic Heart Disease. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months. Unstable angina. Acute illness or active systemic infection or sepsis. Diagnosed atrial myxoma or interatrial baffle or patch. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD). 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. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study. 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. Enrollment in an investigational study evaluating another device, biologic, or drug. Has known pulmonary vein stenosis. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter. Presence of an Inferior Vena Cava (IVC) filter Presence of a condition that precludes vascular access. Life expectancy or other disease processes likely to limit survival to less than 12 months. 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. 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: Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion) Presence of iron-containing metal fragments in the body Unresolved pre-existing neurological deficit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter | Device: Radiofrequency Ablation<br>* RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure) | 
| Number of Participants With Serious Adverse Device Effects (SADEs) | An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. | Up to 405 Days | 
| Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure | Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis. | Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days) | 
| Number of Participants With Non-serious Adverse Events | An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device. | Up to 405 Days | 
| Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli | Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported. | Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days) | 
| Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli | Number of participants with symptomatic and asymptomatic cerebral emboli was reported | Up to 405 Days | 
| Number of Participants With New or Worsening Neurologic Deficits | Number of participants with new or worsening neurologic deficits was reported. | Pre-procedure, discharge, 1 Month, 3 Month and 6 Month | 
| Number of Participants With NIHSS Scores | The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke). | Pre-procedure and at discharge (Up to 405 Days) | 
| Number of Participants With MoCA Scores | Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16. | Up to 405 Days | 
| Number of Participants With Hospitalization for Cardiovascular Events | Hospitalization was defined as prolonged stay greater than or equal to (>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure >= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition. | Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days) | 
| Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants | Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters. | Up to 405 Days | 
| Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers | Percentage of participants with use of focal catheter ablation for non-PV triggers was reported. | Up to 405 Days | 
| Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL | Percentage of participants with six-month arrythmia recurrence [defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes >30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)] was reported. | Up to 6 Months | 
| Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL | Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode >30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure. | Up to 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency Ablation, Paroxysmal Atrial Fibrillation