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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03723070
Ethics application status
Date submitted
28/11/2017
Date registered
29/10/2018
Date last updated
10/03/2020

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: Proportion of participants with procedure related adverse events OR device related adverse events OR Serious Adverse device effects - Proportion 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)
Timepoint [1] 0 0
12 Months
Primary outcome [2] 0 0
Acute procedural success - Proportion of patients achieving pulmonary vein isolation defined as entrance and exit block for each of the targeted pulmonary veins following the last ablation application.
Timepoint [2] 0 0
end of the PVI ablation at the index procedure
Primary outcome [3] 0 0
Treatment Failure - 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
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Secondary safety outcome: Proportion of patients experiencing procedure-related or device related adverse events. - Proportion of patients experiencing procedure-related or device related adverse events.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
acute pulmonary veins conduction reconnection - count of total number of veins that present entrance and exit block immediately after ablation but not 30 min after last ablation application
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
Gender
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
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Multi-center, open label, prospective clinical study to establish the acute safety and
performance of the Cryterion Cardiac Cryoablation System
Trial website
https://clinicaltrials.gov/show/NCT03723070
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

Summary results
Other publications