Atrial Fibrillation, Atrial Flutter
Conditions
Keywords
Surgical ablation, Cryo probe
Brief summary
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
Detailed description
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this study will be used for submission to regulatory authorities in Europe, China and other geographies as needed.
Interventions
DEVICESurgical Ablation
The AtriCure cryoICE® cryoFORMTM cryoablation probe is used in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
Sponsors
AtriCure, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is greater than or equal to 18 years of age. 2. Subject has documented history of atrial fibrillation. 3. Subjects who received surgical ablation for their atrial fibrillation using CRYOF and on whom at least the following lesions were performed: Left and right pulmonary vein isolation, roof and floor lines, mitral annulus line and a connecting lesion from left atrial appendage to left pulmonary vein coronary sinus lesion and LAA exclusion , with a lesion duration of at least 2 minutes. 4. Stable subject that underwent non-emergent cardiac surgical procedure(s) on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, or coronary artery bypass procedures, or atrial septal defect (ASD) repair 5. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history). 6. Subject is willing and able to provide written informed consent. 7. Subject is willing and able to return for scheduled follow-up visits.
Exclusion criteria
1. Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery. 2. Previous left sided ablation procedures procedure. 3. Untreated atrial flutter and symptomatic ventricular arrythmia 4. Known carotid artery stenosis greater than 80% prior to index ablation procedure. 5. Prior history of ischemic stroke or hemorrhagic stroke 6. History of MI with ST elevation within 6 weeks prior to the index ablation 7. Documented AF duration of greater than 10 years. 8. Large left atrial size i.e., LA diameter \>7 cm prior to the index ablation procedure. 9. Subjects with active systemic infection prior to index ablation procedure. 10. Subjects who had documented severe peripheral arterial occlusive disease defined as claudication with minimal exertion prior to the ablation procedure. 11. Subjects with history of renal failure requiring dialysis or hepatic failure prior to the ablation procedure. 12. A known drug and/or alcohol addiction. 13. Mental impairment or other conditions which may not allow the subject to understand the nature, significance, and scope of the study. 14. Subjects who are pregnant 15. Subjects who had preoperative need for mechanical circulatory support or intravenous inotropes. 16. Subjects who are on anti-arrhythmic drug therapy for the treatment of another arrhythmia. 17. Subjects in currently undergoing chemotherapy. 18. Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases). 19. Subjects who had known connective tissue disorders at the time of index ablation procedure 20. Subjects who had known hypertrophic obstructive cardiomyopathy at the time of index ablation procedure 21. Subjects with known cold agglutinin. 22. Subjects who had or tested positive for COVID-19 23. Subjects with bleeding disorders and/or inability to receive anticoagulation 24. Subjects undergoing aortic dissection surgery as index procedure. 25. Cardiac surgical re-intervention since the index cardiac surgery with concomitant AF ablation procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events. | 30 days post procedure | Death, stroke (regardless of level of disability), myocardial infarction, and major bleeding events within 30-days of the index ablation procedure. Measured by number of patients with Treatment-Related Adverse Events. |
| Freedom From Any Documented AF, AFL or AT Lasting >30 Seconds in the Duration of the Last Follow-up Visit Off Antiarrhythmic Therapy (Except of AADs at Doses Not Exceeding Those Previously Failed | 12-24 months post procedure | Freedom from any documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) lasting \>30 seconds in duration at the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed). Measured by 24-hour Holter Monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless of Class I or III AADs | 12-24 months post procedure | Freedom from any documented AF, AFL, or AT lasting \>30 seconds at the last follow-up visit regardless of Class I or III AADs. |
| Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit in the Absence of Class I or III AADs. | 12-24 months post procedure | Freedom from any documented AF, AFL, or AT lasting \>30 seconds at the last follow-up visit in the absence of Class I or III AADs. |
| Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure. | At end of procedure | Acute procedural success defined as documentation of sinus rhythm at the end of the procedure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Pacemaker Implant or Overall Device or Surgical Ablation Procedures Related to Adverse Events | 12-24 months post procedure | Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Randomized, Single Arm Study Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Non-Randomized, Single Arm Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 68.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 1 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 12 / 33 |
Outcome results
Primary
Freedom From Any Documented AF, AFL or AT Lasting >30 Seconds in the Duration of the Last Follow-up Visit Off Antiarrhythmic Therapy (Except of AADs at Doses Not Exceeding Those Previously Failed
Freedom from any documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) lasting \>30 seconds in duration at the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed). Measured by 24-hour Holter Monitoring.
Time frame: 12-24 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Randomized, Single Arm Study | Freedom From Any Documented AF, AFL or AT Lasting >30 Seconds in the Duration of the Last Follow-up Visit Off Antiarrhythmic Therapy (Except of AADs at Doses Not Exceeding Those Previously Failed | 25 Participants |
Primary
Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events.
Death, stroke (regardless of level of disability), myocardial infarction, and major bleeding events within 30-days of the index ablation procedure. Measured by number of patients with Treatment-Related Adverse Events.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Randomized, Single Arm Study | Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events. | 0 Participants |
Secondary
Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure.
Acute procedural success defined as documentation of sinus rhythm at the end of the procedure.
Time frame: At end of procedure
Secondary
Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit in the Absence of Class I or III AADs.
Freedom from any documented AF, AFL, or AT lasting \>30 seconds at the last follow-up visit in the absence of Class I or III AADs.
Time frame: 12-24 months post procedure
Secondary
Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless of Class I or III AADs
Freedom from any documented AF, AFL, or AT lasting \>30 seconds at the last follow-up visit regardless of Class I or III AADs.
Time frame: 12-24 months post procedure
Other Pre-specified
Freedom From Pacemaker Implant or Overall Device or Surgical Ablation Procedures Related to Adverse Events
Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events
Time frame: 12-24 months post procedure