Longstanding Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Surgical Ablation, Maze Procedure, AF
Brief summary
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.
Detailed description
Introduction: Among the cardiac arrhythmias, Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population and represents an increasing problem worldwide. Management strategies for AF include combinations of various treatments, including surgery. Cox et al. developed the surgical Maze procedure to restore sinus conduction to the AV node and to restore effective, synchronized bi-atrial contraction. In an effort to address the observed challenges and make this treatment available to more subjects, modifications of the Maze pattern and new lesion patterns have being developed and tested. Devices using new technologies, like cryothermia, were developed in an effort to reduce the time required to make the lesion pattern.The Cardioblate® CryoFlex™ Surgical Ablation System has been successfully used for the surgical ablation of cardiac arrhythmias including atrial fibrillation. The system utilizes cryothermia to create the linear lesions of the surgical Maze-III procedure. Purpose: To provide clinical evidence showing that the Cox Cryo Maze III procedure is effective and safe in subjects with longstanding persistent AF undergoing mitral valve repair or replacement. Study objective: The study objectives were to characterize the safety and efficacy of the Medtronic Cardioblate CryoFlex Surgical Ablation System when used to treat subjects with longstanding persistent AF requiring concomitant mitral valve repair or replacement.
Interventions
DEVICECardioblate CryoFlex Surgical Ablation
Longstanding persistent AF was treated with the Cox Cryo Maze III procedure During mitral valve surgery a surgical ablation was performed, using the Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
PROCEDUREMitral Valve surgery
Classic mitral valve surgery was performed
DEVICEMedtronic Reveal XT Insertable Cardiac Monitor
During the procedure, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor episodes of AF during follow-up period
PROCEDUREMAZE III
Longstanding persistent AF was treated with the Cox Cryo Maze III procedure
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a documented history of longstanding persistent AF as defined by the HRS/EHRA/ECAS Guidelines * Patients should have a concomitant indication (other than AF) for open-heart surgery for mitral valve repair or replacement (bioprosthesis) * Patients should be older than or equal to 18 years of age
Exclusion criteria
* Atrioventricular reentrant tachycardia (AVRT) * NYHA Class = IV * Left ejection fraction of ≤ 30% * Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery * Previous atrial fibrillation ablation, AV-nodal ablation, or surgical Maze procedure * Contraindication for anticoagulation therapy * Left atrial diameter \> 7.0 cm * Preoperative need for intra-aortic balloon pump or intravenous inotropes * Renal failure requiring dialysis or hepatic failure * Life expectancy of less than one year * Pregnancy or desire to be pregnant within 12 months of the study treatment * Current diagnosis of active systemic infection * Documented MI 6 weeks prior to study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation. | 12 months | The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden \< 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period. |
| Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | 30 days | The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | 12 Months | — |
| AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months | 3, 6 and 12 Months | AF burden is defined as percentage of time the patient is in AF during 24 hours. |
| Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | 6 and 12 months | The 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale. |
| Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | 12 months | The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention |
Countries
Germany, Israel, Italy, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardioblate CryoFlex Surgical Ablation Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery
Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Reveal XT was explanted | 1 |
| Overall Study | Subject received other treatment | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Cardioblate CryoFlex Surgical Ablation |
|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 7.9 |
| NYHA Class NYHA Class I | 3 Participants |
| NYHA Class NYHA Class II | 11 Participants |
| NYHA Class NYHA Class III | 3 Participants |
| NYHA Class NYHA Class IV | 0 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 17 |
| other Total, other adverse events | 3 / 17 |
| serious Total, serious adverse events | 9 / 17 |
Outcome results
Primary
Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation.
The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden \< 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period.
Time frame: 12 months
Population: There were 11 subjects with data at 12 months, including antiarrhythmic drug, ablation, and cardioversion data. However, only six subjects had the AF burden data required for the primary efficacy endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation. | 5 Participants |
Primary
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention
Time frame: 30 days
Population: All subjects treated with the Cardioblate Cryoflex Surgical Ablation System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Esophageal Injury | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Cardiac Death | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Non-Cardiac Death | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Stroke | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Transient Ischemic Attack | 1 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Pulmonary Embolism | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Peripheral Arterial Embolism | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Myocardial Infarction | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Mediastinitis | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Cardiac Injury related to the use of Ablation | 0 Participants |
Secondary
AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months
AF burden is defined as percentage of time the patient is in AF during 24 hours.
Time frame: 3, 6 and 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months | 3.0 percentage of AF burden | Standard Deviation 6.7 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months | 1.3 percentage of AF burden | Standard Deviation 2.8 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months | 2.4 percentage of AF burden | Standard Deviation 5.5 |
Secondary
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
The 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale.
Time frame: 6 and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Bodily Pain | 45.3 units on a scale | Standard Deviation 13 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Mental Health | 46.6 units on a scale | Standard Deviation 10.1 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Social Functioning | 43.9 units on a scale | Standard Deviation 13 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Role Physical | 37.3 units on a scale | Standard Deviation 13.2 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Physical Component Summary (PCS) | 38.0 units on a scale | Standard Deviation 10.4 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Physical Functioning | 36.6 units on a scale | Standard Deviation 12.8 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Mental Component Summary (MCS) | 47.2 units on a scale | Standard Deviation 10.3 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Vitality | 49.6 units on a scale | Standard Deviation 12.3 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Role Emotional | 39.0 units on a scale | Standard Deviation 14.5 |
| Cardioblate CryoFlex Surgical Ablation | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | General Health | 36.9 units on a scale | Standard Deviation 10.8 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Role Emotional | 47.3 units on a scale | Standard Deviation 12.4 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Mental Component Summary (MCS) | 52.7 units on a scale | Standard Deviation 12 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Physical Functioning | 46.6 units on a scale | Standard Deviation 10.6 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | General Health | 48.4 units on a scale | Standard Deviation 8.7 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Mental Health | 53.2 units on a scale | Standard Deviation 11.7 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Role Physical | 45.3 units on a scale | Standard Deviation 10 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Bodily Pain | 50.9 units on a scale | Standard Deviation 11.7 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Vitality | 53.5 units on a scale | Standard Deviation 11 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Social Functioning | 50.8 units on a scale | Standard Deviation 9.5 |
| AF Burden in Treated Subjects After 6 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Physical Component Summary (PCS) | 46.7 units on a scale | Standard Deviation 10 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Bodily Pain | 52.3 units on a scale | Standard Deviation 7.2 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | General Health | 46.7 units on a scale | Standard Deviation 9.3 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Physical Functioning | 42.7 units on a scale | Standard Deviation 11.6 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Social Functioning | 49.5 units on a scale | Standard Deviation 9.6 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Vitality | 54.8 units on a scale | Standard Deviation 6.8 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Mental Health | 54.8 units on a scale | Standard Deviation 10 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Mental Component Summary (MCS) | 56.1 units on a scale | Standard Deviation 9.7 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Role Physical | 43.4 units on a scale | Standard Deviation 11.9 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Role Emotional | 51.0 units on a scale | Standard Deviation 7.7 |
| AF Burden in Treated Subjects After 12 Months Follow-Up | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | Physical Component Summary (PCS) | 43.4 units on a scale | Standard Deviation 9.4 |
Secondary
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | 3 Participants |
Secondary
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
Time frame: 12 Months
Population: All subjects who underwent ablation therapy and who had data from the Reveal XT Insertable Cardiac Monitor
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | 5 Participants |
Secondary
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | 4 Participants |
Secondary
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Cardiac Death | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Non-Cardiac Death | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Stroke | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Transient Ischemic Attack (TIA) | 1 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Pulmonary Embolism | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Peripheral Arterial Embolism | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Mediastinitis | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Esophageal Injury | 0 Participants |
| Cardioblate CryoFlex Surgical Ablation | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | Cardiac Injury related to the use of Ablation | 0 Participants |