Atrial Fibrillation
Conditions
Brief summary
Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
Detailed description
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.
Interventions
DEVICEThe 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
Sponsors
Cryterion Medical, Inc.
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-randomized study designed to validate the safety and performance of the Cryterion Cardiac Cryoablation System when used as intended
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects | 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) |
| Acute Procedural Success | 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. |
| 12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events. | 12 months | All procedure-related or device related adverse events with causal relationship |
| Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing | 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. |
Countries
Croatia, Netherlands, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ended the study at 1 month follow-up visit as per applicable protocol at that time | 6 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | PV Cryoablation |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Region of Enrollment Croatia | 64 participants |
| Region of Enrollment Netherlands | 9 participants |
| Region of Enrollment New Zealand | 15 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 88 |
| other Total, other adverse events | 56 / 88 |
| serious Total, serious adverse events | 6 / 88 |
Outcome results
Primary
12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 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
Time frame: 12 months
Population: In total, 88 subjects were enrolled. Six subjects ended the study at the one month follow-up visit and were therefore not eligible for the analysis. Of the 3 subjects that were withdrawn prior to study completion, one subject experienced a recurrence before being withdrawn and was therefore included in the analysis. The two other subjects were event free at time of study withdrawal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PV Cryoablation | 12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months | 58 Participants |
Primary
Acute Procedural Success
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.
Time frame: Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PV Cryoablation | Acute Procedural Success | 87 Participants |
Primary
Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects
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)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PV Cryoablation | Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects | 50 Participants |
Secondary
Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing
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.
Time frame: 30 minutes
Population: Out of 88 subjects enrolled in the study, 54 subjects have been enrolled under the protocol requiring a 30 minute waiting period between pulmonary vein isolation and entrance/exit block testing. All subjects for whom at least one additional application was performed minimally 30 minutes after the previous ablation, were considered having a potential reconnection during entrance/exit block testing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PV Cryoablation | Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing | 7 Participants |
Secondary
Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events.
All procedure-related or device related adverse events with causal relationship
Time frame: 12 months
Population: Causally related to procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PV Cryoablation | Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events. | 12 Adverse Events |