Persistent Atrial Fibrillation
Conditions
Brief summary
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.
Interventions
DEVICETactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF
Sponsors
Abbott Medical Devices
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. Patient must provide written informed consent prior to any clinical investigation related procedure. 2. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF 3. Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF 4. Age 18 years or older 5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
1. Continuous AF \> 12 months (longstanding persistent AF) 2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar 3. Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure 4. CABG surgery within the 6-months (180-days) prior to the initial procedure 5. Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve) 6. Any carotid stenting or endarterectomy 7. Documented or known left atrial thrombus on imaging 8. Left atrial diameter \> 50 mm (parasternal long axis view or by CT) 9. Left ventricular ejection fraction \< 40% 10. Unable to take anticoagulation medication due to contraindication or intolerance 11. History of blood clotting or bleeding abnormalities 12. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure 13. Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure 14. Rheumatic heart disease 15. Uncontrolled heart failure or NYHA functional class III or IV 16. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2) 17. Awaiting cardiac transplantation or other cardiac surgery within the 12-months (365 days) following the initial ablation procedure 18. Unstable angina at the time of the initial procedure 19. Acute illness or active systemic infection or sepsis 20. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, major surgical procedure in the preceding 3-months, or other reversible or non-cardiac cause 21. Diagnosed atrial myxoma 22. Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) 23. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms 24. Significant congenital anomaly or other anatomic or comorbid medical problem that in the opinion of the investigator would preclude enrollment in this study or compliance with the follow-up requirements or impact the scientific soundness of the clinical trial results 25. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 26. Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure 27. Presence of any condition that precludes appropriate vascular access or manipulation of catheter 28. Life expectancy less than 12-months 29. Body mass index \> 40 kg/m2 30. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 31. Renal failure requiring dialysis 32. Vulnerable subject 33. History of atriotomy or ventriotomy 34. Implanted endocardial left atrial appendage occlusion device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Subjects With a Device and/or Procedure-related SAE. | Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure | Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device. |
| Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. | 15 months | The following events were considered a failure for AF/AFL/AT recurrence: * If AF/AFL/AT recurrence (\>30 second episode) occurred at any time after the therapy consolidation period (\>180 days after the initial procedure), or * If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a \>30 second AF/AFL/AT episode, or * If the subject required a second repeat procedure at any time after the initial procedure, or * If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or * If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or * If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Success | Immediate post procedure | Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins |
| 15-month Success Off of Antiarrhythmic Drugs | 15 months | Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods. |
| 15 Month Single Procedure Success | 15 months | Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis. |
Countries
Australia, United States
Participant flow
Recruitment details
A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Pre-assignment details
One subject was withdrawn after meeting enrollment criteria but prior to procedure with the investigational device.
Participants by arm
| Arm | Count |
|---|---|
| Ablation All enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment | 223 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Enrolled, but no ablation performed-investigational catheter was not inserted | 1 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Subject did not complete follow-up but did not meet criteria for lost-to-follow-up | 4 |
| Overall Study | Withdrawal by Subject | 20 |
Baseline characteristics
| Characteristic | Ablation |
|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 209 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 213 Participants |
| Region of Enrollment Australia | 14 Participants |
| Region of Enrollment United States | 209 Participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 224 |
| other Total, other adverse events | 29 / 224 |
| serious Total, serious adverse events | 59 / 224 |
Outcome results
Primary
Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.
The following events were considered a failure for AF/AFL/AT recurrence: * If AF/AFL/AT recurrence (\>30 second episode) occurred at any time after the therapy consolidation period (\>180 days after the initial procedure), or * If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a \>30 second AF/AFL/AT episode, or * If the subject required a second repeat procedure at any time after the initial procedure, or * If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or * If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or * If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the
Time frame: 15 months
Population: The analysis population for the primary effectiveness endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled | Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. | 114 Participants |
Primary
Rate of Subjects With a Device and/or Procedure-related SAE.
Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.
Time frame: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure
Population: The analysis population for the primary safety endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 7-day follow-up visit; or crossed the end of the 7-day visit window without the visit but with a primary safety endpoint event
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled | Rate of Subjects With a Device and/or Procedure-related SAE. | 7 Participants |
Secondary
15 Month Single Procedure Success
Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.
Time frame: 15 months
Population: The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled | 15 Month Single Procedure Success | 110 Participants |
Secondary
15-month Success Off of Antiarrhythmic Drugs
Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods.
Time frame: 15 months
Population: The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled | 15-month Success Off of Antiarrhythmic Drugs | 89 Participants |
Secondary
Acute Procedural Success
Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins
Time frame: Immediate post procedure
Population: The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled | Acute Procedural Success | 219 Participants |