Clinical trial NCT03723070: Cryoablation System FIM/CE Mark Study
Official title: Cryterion Cardiac Cryoablation System CE Mark Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Cryterion Medical, Inc.
First posted: 2018-10-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized study designed to validate the safety and performance of the Cryterion Cardiac Cryoablation System when used as intended
Primary purpose: TREATMENT

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.

Eligibility criteria: Main Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects
timeFrame: 12 months
measure: Acute Procedural Success
timeFrame: Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes.
measure: 12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events.
timeFrame: 12 months
measure: Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Clinical Hospital Centre Split
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Sarfaraz Taher
role: STUDY_DIRECTOR
References:
citation: Anic A, Lever N, Martin A, Breskovic T, Sulkin MS, Duffy E, Saliba WI, Niebauer MJ, Wazni OM, Varma N. Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience. Europace. 2021 Aug 6;23(8):1237-1243. doi: 10.1093/europace/euab018.
citation: Martin A, Fowler M, Breskovic T, Ouss A, Dekker L, Yap SC, Bhagwandien R, Albrecht EM, Cielen N, Richards E, Tran BC, Lever N, Anic A. Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study. J Interv Card Electrophysiol. 2022 Dec;65(3):609-616. doi: 10.1007/s10840-022-01200-5. Epub 2022 Apr 12.