At a glance
ClinicalIndex Comparison RecordN/ACompleted· 88 enrolled
Drug / intervention
The Cryterion Cardiac Cryoablation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cryterion Cardiac Cryoablation System CE Mark Study
In Brief
A clinical study evaluating The Cryterion Cardiac Cryoablation System for Atrial Fibrillation. Completed, enrolled 88 participants across 4 sites in 3 countries.
Detailed Summary
Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesCroatia, Netherlands, New Zealand
CollaboratorsCryterion Medical, Inc.
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedOct 2018
Primary CompletionDec 2020
TodayJul 2026
First PostedOct 29, 2018
Enrollment StartMay 15, 2018
Primary CompletionDec 22, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.7 years ago
Interventions
The Cryterion Cardiac Cryoablation Systemdevice
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