Persistent Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation, Radiofrequency Ablation, Heart Disease, Tachycardia, Cardiovascular Diseases, Cardiac Conduction System Disease, Atrial Fibrillation
Brief summary
The objective of this clinical trial is to collect safety and effectiveness data for the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the APAC patient population for the treatment of drug refractory, symptomatic persistent atrial fibrillation when following standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
Detailed description
The PerAF APAC trial is a prospective, single arm, non-randomized, observational, post-market clinical investigation. Approximately 100 subjects will be enrolled at up to 15 sites in South Korea, Singapore, Hong Kong, Taiwan, and India. Centers in other countries within APAC may be approached for participation in the clinical investigation as needed. Subjects will be followed for 15-months after their initial ablation procedure. The primary effectiveness and safety endpoints will be evaluated through 15-months. A core lab will independently assess AF/Atrial Flutter (AFL)/(Atrial tachycardia (AT) recurrence via Holter monitoring at the 6-month and 15-month follow-up visits. All serious adverse events (SAEs) will be independently adjudicated by qualified physicians not participating in the trial
Interventions
DEVICETactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)
TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Documented symptomatic persistent AF, defined as continuous AF sustained \>7-days but \<1 year documented by: 1. Physician's note AND one of the following: 2. 24-hr Holter showing continuous AF within 90-days of the procedure OR 3. 2 ECGs (from any form of rhythm monitoring) showing continuous AF, taken at least 7-days apart 3. Refractory or intolerant to at least one Class I or III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF Note: Intolerant = unable, unwilling, or refusal to take AADs 4. ≥18 years of age 5. Able and willing to complete all pre-, post-, and follow-up testing and requirements
Exclusion criteria
1. Continuous AF \>12 months (longstanding persistent AF) 2. Previous left atrial (LA) surgical or catheter ablation for AF 3. Any cardiac procedure within 90-days prior to initial procedure (Diagnostic procedures with no intervention are not considered a surgical or percutaneous surgical procedure) 4. Coronary artery bypass graft (CABG) surgery within 6-months (180-days) prior to 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 (LA) diameter \>50 mm (parasternal long axis view or by CT) 9. Left Ventricular Ejection Fraction (LVEF) \<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 12-months (365 days) prior to the initial procedure 14. Rheumatic heart disease 15. Uncontrolled heart failure or New York Heart Association (NYHA) 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 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. Presence of other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 33. History of atriotomy or ventriotomy 34. Implanted left atrial appendage occlusion device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device and/or Procedure-related Serious Adverse Events | Through 7-days | device and/or procedure-related serious adverse events are pre-defined as below with onset within 7-days of any ablation procedure that uses the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure) * Atrioesophageal fistula - assessed through 15 months * Cardiac tamponade/perforation - assessed through 15 months * Death * Heart block * Myocardial infarction (MI) * Pericarditis - pleuritic symptoms \>7 days and/or requires hospitalization \>24 hrs for reasons other than observational purposes only * Phrenic nerve injury resulting in diaphragmatic paralysis * Pneumothorax * Pulmonary edema (respiratory insufficiency) * Pulmonary vein stenosis - assessed through 15 months * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vascular access complications (including major bleeding events) |
Countries
Hong Kong, Singapore, South Korea, Taiwan, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug Refractory, Symptomatic Persistent Atrial Fibrillation Asian population
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE): TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study termination | 37 |
| Overall Study | Subject did not meet screening inclusion/exclusion criteria | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Drug Refractory, Symptomatic Persistent Atrial Fibrillation |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 81 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 | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Hong Kong | 6 participants |
| Region of Enrollment Singapore | 12 participants |
| Region of Enrollment South Korea | 38 participants |
| Region of Enrollment Taiwan | 18 participants |
| Region of Enrollment Thailand | 7 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 3 / 81 |
| serious Total, serious adverse events | 16 / 81 |
Outcome results
Primary
Rate of Device and/or Procedure-related Serious Adverse Events
device and/or procedure-related serious adverse events are pre-defined as below with onset within 7-days of any ablation procedure that uses the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure) * Atrioesophageal fistula - assessed through 15 months * Cardiac tamponade/perforation - assessed through 15 months * Death * Heart block * Myocardial infarction (MI) * Pericarditis - pleuritic symptoms \>7 days and/or requires hospitalization \>24 hrs for reasons other than observational purposes only * Phrenic nerve injury resulting in diaphragmatic paralysis * Pneumothorax * Pulmonary edema (respiratory insufficiency) * Pulmonary vein stenosis - assessed through 15 months * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vascular access complications (including major bleeding events)
Time frame: Through 7-days
Population: The primary safety endpoint was the rate of pre-specified device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that used the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure), with the exception of atrio-esophageal fistula, cardiac tamponade/perforation, and pulmonary vein stenosis which were evaluated through 15-months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Refractory, Symptomatic Persistent Atrial Fibrillation | Rate of Device and/or Procedure-related Serious Adverse Events | 3 Participants |