Atrial Fibrilation - Abnormal heart rhythm
Conditions
Interventions
None listed
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • History of recurrent symptomatic paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. • No amiodarone use within 90 days prior to enrollment • Subjects who are indicated for an ablation procedure for paroxysmal atrial fibrillation (PAF) according to 2017 HRS expert consensus statement on catheter and surgical ablation of atrial fibrillation • Subjects refractory or intolerant to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications • Subjects who are willing and capable of providing informed consent • Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center • Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
Exclusion criteria
Exclusion criteria: • Any known contraindication to an AF ablation or anticoagulation • Continuous AF lasting longer than seven (7) days from onset • History of previous left atrial ablation or surgical treatment for AF/ AFL/ AT • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause • Structural heart disease or implanted devices as described below: a. Left ventricular ejection fraction (LVEF) 5.5 cm OR left atrial volume > 50 ml/m2 indexed based on the most recent TTE performed 30 mmHg(1)] m. Evidence of left atrial thrombus** • Any previous history of cryoglobulinemia • Stage 3B or higher renal disease (estimated glomerular filtration rate, eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: Primary safety event free rate at 12 months post procedure. Primary safety events will consist of a composite of the following procedure-related and device-related adverse events. Acute primary safety endpoint events, events occurring up to 7 days post index or hospital discharge, whichever is later, include: • Death • Myocardial infarction (MI) • Transient ischemic attack (TIA) • Stroke/ Cerebrovascular accident (CVA) • Vascular access complications • Mitral or tricuspid valvular damage • Thromboembolism/ Air embolism leading to a life-threatening event such as a ventricular arrhythmia, stroke, pulmonary embolism, or myocardial infarction and, thromboembolic events that result in permanent injury, require intervention for treatment or prolongs or require hospitalization for more than 48 hours • Gastroparesis/injury to vagus nerve • Pneumothorax • Pulmonary edema/heart failure • AV block Cardiac tamponade/perforation, occurring up to 30 days post index procedure. Chronic primary safety endpoint events, events occurring through 12 months post procedure, include: • Atrial esophageal fistula • Severe Pulmonary vein stenosis (>= 70% reduction in the diameter of the PV or PV branch from baseline) • Persistent phrenic nerve palsy Primary Effectiveness Endpoint: Failure free rate at 12 months post procedure. Failure defined as: • Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period • Use of amiodarone post index procedure • Surgical treatment for AF/AFL/AT post index procedure • Use of a non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period • More than one repeat procedure with the POLARx catheter during the blanking period (90 days post index procedure) • Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event [>= 30 seconds in duration from the study speci | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety Endpoint Safety: Reportable Adverse Events rates at 12 months. Adverse events will be collected at all subject follow-up visits. Reportable events include: • All Serious Adverse Events • All Study Procedure-Related Adverse Events • All Study Device-Related Adverse Events • All Study Device Deficiencies • Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in Investigator*s Brochure or DFU Secondary Effectiveness Endpoint Rate of acute procedural success defined as the achievement of electrical isolation of all PVs by using the POLARx Cardiac Cryoablation system only. Electrical isolation of a PV is demonstrated by entrance and exit block. Additional Endpoints Additional endpoints and analysis include, but are not limited to: • Changes in the quality of life measures (AFEQT and EQ-5D-5L) between baseline and 12 months follow up • Single procedure success defined as freedom from primary effectiveness failure without a repeat procedure • Duration of LA dwell time, defined as time from the Cryoablation Catheter exiting the sheath in the LA to time of final PV isolation • Total Cryoablation time for the index procedure; • Total fluoroscopy time for the index procedure; • Total index procedure time. • Freedom from recurrence of individual types of atrial arrhythmias between 91 and 365 days from index procedure: 1) AF 2) AT 3) AFL • Failure-free rate as defined in primary effectiveness endpoint at 6 months post procedure • Failure- free rate as defined in primary effectiveness endpoint when considering AF/AT/AFL episodes reported to the investigators by study specific (event recorder transmissions, 12 lead ECG and Holter) and non-study related devices (other commercial applications for arrhythmia monitoring and detection the subject may access during the study including telemetry, other sources of continuous recording etc.) | — |
Countries
Netherlands
Outcome results
None listed