Cryoablation System FIM/CE Mark Study

Atrial Fibrillation Clinical Trial

Official title:

Cryterion Cardiac Cryoablation System CE Mark Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723070
• Other study ID #: CEM-A02-02
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: December 22, 2020

Study information

• Verified date: June 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System

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 information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• The Cryterion Cardiac Cryoablation System
Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre Split	Split
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Erasmus MC	Rotterdam
New Zealand	Auckland City Hospital	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Cryterion Medical, Inc.

Countries where clinical trial is conducted

Croatia,  Netherlands,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects	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)	12 months
Primary	Acute Procedural Success	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.	Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes.
Primary	12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 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	12 months
Secondary	Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events.	All procedure-related or device related adverse events with causal relationship	12 months
Secondary	Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing	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.	30 minutes