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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03723070




Registration number
NCT03723070
Ethics application status
Date submitted
28/11/2017
Date registered
29/10/2018

Titles & IDs
Public title
Cryoablation System FIM/CE Mark Study
Scientific title
Cryterion Cardiac Cryoablation System CE Mark Study
Secondary ID [1] 0 0
CEM-A02-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - The Cryterion Cardiac Cryoablation System

Experimental: PV Cryoablation - 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


Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Acute Procedural Success
Timepoint [2] 0 0
Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes.
Primary outcome [3] 0 0
12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing
Timepoint [2] 0 0
30 minutes

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/12/2020
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Croatia
State/province [1] 0 0
Split
Country [2] 0 0
Netherlands
State/province [2] 0 0
Eindhoven
Country [3] 0 0
Netherlands
State/province [3] 0 0
Rotterdam
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Cryterion Medical, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarfaraz Taher
Address 0 0
Boston Scientific Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03723070