Cryoablation System FIM/CE Mark Study
- Conditions
- Atrial Fibrillation
- Interventions
- Device: The Cryterion Cardiac Cryoablation System
- Registration Number
- NCT03723070
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
- Detailed Description
This is a single-arm, open-label clinical study using a cryoablation balloon device to isolate pulmonary veins during an atrial fibrillation ablation procedure. Cryo is a scientifically proven energy source used to create a thermal injury during endocardial ablation. The investigational device uses current technology with minor design modifications and will be studied to validate similarities in the safety and performance parameters compared to literature.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Currently scheduled for a de novo ablation of atrial fibrillation (AF) defined as AF with self-terminating episodes lasting no longer than 7 continuous days (PAF)
Main
- In the opinion of the Investigator, any known contraindication to an AF ablation, Transesophageal Echocardiogram (TEE). or anticoagulation
- Any duration of continuous AF lasting longer than 7 days
- History of previous left atrial ablation or surgical treatment for Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia (AF/AFL/AT)
- More than four (4) electrical cardioversions in the year prior to enrollment excluding cardioversions performed within 24 hours of arrhythmia onset.
- Significant structural heart disease or implanted cardiac devices
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PV Cryoablation The Cryterion Cardiac Cryoablation System Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System
- Primary Outcome Measures
Name Time Method Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects 12 months Percentage of participants with procedure related adverse events OR device related adverse events OR Serious Adverse device effects including: Death, Myocardial Infarction, Cardiac perforation/pericardial tamponade, Cerebral Infarct or systemic embolism, Major bleeding requiring transfusion of blood products, Mitral or tricuspid valvular damage, phrenic nerve damage causing persistent diaphragmatic paralysis, Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, Air embolism leading to life-threatening event, other serious adverse device effects (SADEs)
Acute Procedural Success Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes. Percentage of patients achieving pulmonary vein isolation defined as entrance and exit block for each of the targeted pulmonary veins following the last ablation application.
12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months 12 months A treatment failure is defined as a subject being an acute procedural failure, having more than one repeat procedure during the 90-day blanking period or having a documented, symptomatic episode(s) of atrial fibrillation or atrial tachycardia, between 91 and 365 days post index procedure. Occurrence or recurrence of a right atrial arrhythmia is not considered a treatment failure post the 90-day blanking period
- Secondary Outcome Measures
Name Time Method Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events. 12 months All procedure-related or device related adverse events with causal relationship
Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing 30 minutes Percentage of subjects that present PV isolation immediately after ablation but show reconnection after 30 minutes during entrance/exit block testing.
This outcome is only measured in subjects that were enrolled under the protocol that required a 30 minute waiting period between isolation and verification of isolation.
Trial Locations
- Locations (4)
Erasmus MC
🇳🇱Rotterdam, Netherlands
Clinical Hospital Centre Split
ðŸ‡ðŸ‡·Split, Croatia
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand