N/A
Completed N=88
Cryoablation System FIM/CE Mark Study
Source: ClinicalTrials.gov NCT03723070 ↗Enrolled (actual)
88
Serious AEs
6.8%
Results posted
Jul 2021
Primary outcomePrimary: Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects — 50 Participants
Summary
Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects |
50 | — |
| PRIMARY Acute Procedural Success |
87 | — |
| PRIMARY 12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months |
58 | — |
| SECONDARY Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events. |
12 | — |
| SECONDARY Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing |
7 | — |
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
Data sourced from ClinicalTrials.gov (NCT03723070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.