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Completed

NCT Number: NCT03723070

Cryoablation System FIM/CE Mark Study

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital Centre Split, Split, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Cryterion Cardiac Cryoablation System

Device

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

Primary outcomes

  1. Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects

    Time frame: 12 months

    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)

  2. Acute Procedural Success

    Time frame: Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes.

    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.

  3. 12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months

    Time frame: 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

Secondary outcomes

  1. Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events.

    Time frame: 12 months

    All procedure-related or device related adverse events with causal relationship

  2. Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing

    Time frame: 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Cryterion Medical, Inc.

Registry information

Official study title

Cryterion Cardiac Cryoablation System CE Mark Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2018
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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