Atrial Fibrilation
Conditions
Interventions
None listed
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use; 2. Subjects who are willing and capable of providing informed consent; 3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center; 4. 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: 1. Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use; 2. Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use; 3. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause; 4. Known or pre-existing severe Pulmonary Vein Stenosis; 5. Evidence of myxoma, LA thrombus or intracardiac mural thrombus; 6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment; 7. Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment; 8. Implanted Left Atrial Appendage Closure device prior to the index procedure; 9. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder; 10. Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings); 11. Presence of any pulmonary vein stents; 12. Active systemic infection; 13. Vena cava embolic protection filter devices and/ or known femoral thrombus; 14. Any previous history of cryoglobulinemia; 15. History of blood clotting or bleeding disease; 16. Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Saferty Endpoint: Safety event free rate at 12 months post-index 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 postindex procedure or hospital discharge, whichever is later, include: • Death • Myocardial infarction (MI) • Persistent gastroparesis/injury to vagus nerve • Transient ischemic attack (TIA) • Stroke/Cerebrovascular accident (CVA) • Thromboembolism/Air embolism* • Cardiac tamponade/perforation • Pneumothorax • Serious vascular access complications** • Pulmonary edema/heart failure • AV block not attributable to medication effect or vasovagal reaction. * Thromboembolic or /air embolic events collected in the study refer to any occlusion of blood vessel(s) that results in clinical symptoms ** Defined as prolongation of hospitalization, requirement of surgical intervention or blood transfusion Chronic primary safety endpoint events, events occurring through 12 months post-index procedure, include: • Atrial esophageal fistula • Pulmonary vein stenosis (>= 70% reduction of diameter) • Symptomatic pericardial effusion • Persistent Phrenic nerve injury*** ***A non-recovered phrenic nerve injury at 12 months post-index procedure will count as a chronic primary endpoint. The study will collect information on phrenic nerve palsy observed before the end of the index procedure and, in case it occurred, will track information for potential recovery during the study visits. Primary Effectiveness Endpoint: Failure free rate at 12 months post-index procedure. Failure defined as: • Failure to achieve acute procedural success* in the index procedure; • More than one repeat procedure during the blanking period (within 90 days post-index procedure); • Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (>= 30 seconds in duration or from | — |
Secondary
| Measure | Time frame |
|---|---|
| Documentation and rate of acute procedural success, defined as pulmonary vein isolation achieved with the Cryoablation System. Electrical isolation of a PV is demonstrated at minimum by entrance block using the Cryo Mapping Catheter (Other techniques of assessment are per investigator*sdiscretion). Information on isolation method used per site standard of care will be collected with a minimum by entrance block in all PVs or anatomical equivalents. Additional data, if available, will be collected on Exit Block or Conduction Block verification using 3D mapping. Additional endpoints: Additional endpoints and analyses include, but are not limited to: • Procedure times: LA dwell time*, total ablation time, number of cryo applications per vein, time to thaw, total fluoroscopy time and total procedure time; • Time-To-Isolation per ablation application, if available; • Freedom from recurrence of individual types of atrial arrhythmias (AF, AFL, AT) between days 91 and days 365 post-index procedure; • Analysis of ablation techniques (i.e. segmental approach to left common trunk, additional linear ablations, etc.); • Analysis of different anaesthesia techniques (General anaesthesia with or without intubation versus sedation); • Freedom from recurrence in subjects with non-common anatomical configurations of PV (e.g. left common trunk); • Freedom from primary effectiveness failure evaluated in subgroups of subjects (termination of AAD versus continuation of AAD after blanking period); • For the subgroup of subjects undergoing 3D mapping with the Boston Scientific mapping Rhythmia system and performing a post-procedural map, map information will be collected to determine lesion locations; • For subjects that will undergo repeat ablation during the course of the clinical follow-up, anatomical location of ablations gaps will be assessed. * LA dwell time is defined as time from the Cryoablation Catheter introduced in the left atrium (LA) to the last ti | — |
Countries
Netherlands
Outcome results
None listed