Longstanding Persistent Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Ablation, Catheter ablation
Brief summary
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
Interventions
DEVICEHybrid: AtriCure Bipolar System & EP ablation procedure
AtriCure Bipolar System plus a catheter ablation
Sponsors
AtriCure, Inc.
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
1. Age \> 18 years 2. Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent 3. Patient is willing and able to provide written informed consent. 4. Patient has a life expectancy of at least 2 years. 5. Patient is willing and able to attend the scheduled follow-up visits.
Exclusion criteria
1. Prior Cardiothoracic Surgery. 2. Patient has NYHA Class IV heart failure. 3. Evidence of underlying structural heart disease requiring surgical treatment. 4. Ejection fraction \< 30% 5. Measured left atrial diameter \> 6.0 cm 6. Renal Failure 7. Stroke within previous 6 months. 8. Known carotid artery stenosis greater than 80%. 9. Evidence of significant active infection or endocarditis. 10. Pregnant woman or women desiring to become pregnant in the next 24 months. 11. Presence of thrombus in the left atrium determined by echocardiography. 12. History of blood dyscrasia. 13. Contraindication to anticoagulation, based on Investigator's opinion. 14. Mural thrombus or tumor. 15. Moderate to Severe COPD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Atrial Fibrillation | 12 month follow-up | Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy. |
| Primary Safety Endpoint | Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer. | Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Atrial Fibrillation | After the 3 month blanking period through twelve month follow-up. | Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor. |
| Number of Participants With Reintervention to Address Atrial Dysrhythmia | 12 months | Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months |
| Overall Serious Device or Procedure Related Adverse Event Rate | 12 month follow-up | — |
| Improvement in AF | 12 months | Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0) |
| Duration of Procedure | During index procedure | — |
| Number of Participants With DC Cardioversion | 12 months | — |
| Acute Procedure Success | Upon completion of the index procedure, up to ten hours | — |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 5 academic medical centers. The first participant was enrolled in December 2010 and the last participant was enrolled in October 2011.
Participants by arm
| Arm | Count |
|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AtriCure Bipolar System Combined With a Catheter Ablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 60.1 years STANDARD_DEVIATION 8.4 |
| BMI | 30.4 kg/m^2 STANDARD_DEVIATION 4.2 |
| Height | 70.5 inches STANDARD_DEVIATION 2.9 |
| 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 | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 22 Participants |
| Weight | 214.7 pounds STANDARD_DEVIATION 33.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 24 |
| serious Total, serious adverse events | 16 / 24 |
Outcome results
Primary
Absence of Atrial Fibrillation
Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.
Time frame: 12 month follow-up
Population: Denominators (19) are subjects who are evaluable for primary efficacy endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Success at 12 Months | 68.4 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Failure by AAD | 10.5 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Failure by Holter/Pacemaker Interrogation | 21.1 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Atrial Fibrillation | 0.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Atrial Flutter | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Atrial Tachycardia | 21.1 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Failure by both AAD and Holter/Pacemaker Interrog | 0.0 percentage of participants |
Primary
Primary Safety Endpoint
Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Time frame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Pulmonary Embolism per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Death per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Excessive bleeding per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Stroke per IPA | 4.2 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | TIA per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | MI per IPA | 4.2 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Cardiac Tamponade per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Pulmonary Embolism per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Peripheral Embolism per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Atrio-esophageal Fistula per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Diaphragmatic Paralysis per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Pulmonary Vein Stenosis per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | New 2nd/3rd Degree AV Block Requiring PPM per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Serious Skin Burns per IPA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Conversion to Thoracotomy or Sternotomy per IPA | 8.3 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Catheter Related SAEs per IPA | 12.5 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Surgical Procedure Related SAEs per IPA | 20.8 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Death per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Excessive Bleeding per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Stroke per FDA | 4.2 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | TIA per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | MI per FDA | 4.2 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Cardiac Tamponade per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Atrioesophageal Fistula per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Diaphragmatic Paralysis per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Pulmonary Vein Stenosis per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | New 2nd/3rd Degree AV Block Requiring PPM per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Serious Skin Burns per FDA | 0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Conversion to Thoracotomy or Sternotomy per FDA | 8.3 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Primary Safety Endpoint | Catheter Related SAEs per FDA | 8.3 percentage of participants |
Secondary
Absence of Atrial Fibrillation
Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.
Time frame: After the 3 month blanking period through twelve month follow-up.
Population: Denominators are subjects who are evaluable for secondary efficacy endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Free of AF independent of the need for AADs at 12M | 15 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Efficacy Evaluable at 6 months | 22 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Free of AF independent of the need for AADs at 6M | 20 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Absence of Atrial Fibrillation | Efficacy Evaluable at 12 Months | 19 Participants |
Secondary
Acute Procedure Success
Time frame: Upon completion of the index procedure, up to ten hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Inferior Right Pulmonary Veins Isolation Evaluated | 100 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Inferior Right Pulmonary Veins Isolation Achieved | 100 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Inferior Left Pulmonary Veins Isolation Evaluated | 100 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Inferior Left Pulmonary Veins Isolation Achieved | 95.8 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Superior Right Pulmonary Veins Isolation Evaluated | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Superior Right Pulmonary Veins Isolation Achieved | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Superior Left Pulmonary Veins Isolation Evaluated | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Superior Left Pulmonary Veins Isolation Achieved | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Left Atrium Posterior Box Isolation Evaluated | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Left Atrium Posterior Box Isolation Achieved | 54.2 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Bi-drectional block Mitral Valve Isthmus Evaluated | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Bi-drectional block Mitral Valve Isthmus Achieved | 83.3 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Bi-directional block of RC isthmus evaluated | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Bi-directional block of RC isthmus achieved | 83.3 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Superior Vena Cava block evaluated | 100.0 percentage of participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Acute Procedure Success | Superior Vena Cava block achieved | 87.5 percentage of participants |
Secondary
Duration of Procedure
Time frame: During index procedure
Population: Denominators are subjects who are evaluable for secondary efficacy endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Duration of Procedure | Total Surgery Time | 8.9 Hours | Standard Deviation 1.2 |
| AtriCure Bipolar System Combined With a Catheter Ablation | Duration of Procedure | Epicardial Surgical Procedure Time | 3.9 Hours | Standard Deviation 0.9 |
| AtriCure Bipolar System Combined With a Catheter Ablation | Duration of Procedure | EP Catheter Procedure Time | 2.9 Hours | Standard Deviation 1.1 |
Secondary
Improvement in AF
Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0)
Time frame: 12 months
Population: Denominators are subjects who are evaluable for secondary efficacy endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Improvement in AF | Change in AF Symptom Checklist Frequency Score | 13.4 units on a scale | Standard Deviation 8.4 |
| AtriCure Bipolar System Combined With a Catheter Ablation | Improvement in AF | Change in AF Symptom Checklist Severity Score | 9.8 units on a scale | Standard Deviation 7.2 |
Secondary
Number of Participants With DC Cardioversion
Time frame: 12 months
Secondary
Number of Participants With Reintervention to Address Atrial Dysrhythmia
Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Number of Participants With Reintervention to Address Atrial Dysrhythmia | 2 Participants |
Secondary
Overall Serious Device or Procedure Related Adverse Event Rate
Time frame: 12 month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Excessive Bleeding | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Stroke | 1 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | TIA | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | MI | 1 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Cardiac Tamponade | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Pulmonary Embolism | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Peripheral Embolism | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Atrio-esophageal Fistula | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Diaphragmatic Paralysis | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Pulmonary Vein Stenosis | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | New 2nd/3rd Degree AV Block Requiring PPM | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Serious Skin Burns | 0 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Conversion to Thoracotomy or Sternotomy | 2 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Catheter Related SAEs | 2 Participants |
| AtriCure Bipolar System Combined With a Catheter Ablation | Overall Serious Device or Procedure Related Adverse Event Rate | Surgical Procedure Related SAEs | 0 Participants |