Paroxysmal Atrial Fibrillation
Conditions
Brief summary
A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.
Detailed description
The TactiCath Quartz PAS is a prospective, non-randomized, multicenter, interventional study to evaluate the continued safety and effectiveness of the TactiCath Quartz Set for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using contact force assisted irrigated RF ablation. Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated following the standard of care at each study site. After the index procedure, subjects will be followed for a total of 60 months. During the 3-month blanking period following ablation, subjects may undergo up to 2 repeat ablation procedures (up to 10 days prior to end of the blanking period) using the same device used during ablation. Subjects will be evaluated at pre-discharge, at 7 days, at 3, 6 and 12 months post-index procedure and then yearly thereafter. Subjects will complete Holter monitoring at 3- and 6- months post index ablation procedure and at yearly intervals beginning at 12 months post-index ablation procedure.
Interventions
DEVICETactiCath Quartz treatment
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 is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I IV antiarrhythmic drug 2. Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, trans-telephonic event monitor, telemetry strip, or implanted device 3. Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history 4. Patient is 18 years of age or older 5. Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits 6. Patient provides written informed consent prior to enrollment in the study
Exclusion criteria
1. Persistent or long-standing persistent atrial fibrillation (AF) 2. Patient has had 4 or more cardioversions in the past 12 months. 3. Active systemic infection 4. Presence of implantable cardiac defibrillator (ICD) 5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months 6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months 7. Left atrial diameter \> 5.0 cm 8. Left ventricular ejection fraction \< 35% 9. New York Heart Association (NYHA) class III or IV 10. Previous left atrial ablation procedure, either surgical or catheter ablation 11. Patient has had a left atrial surgical procedure or incision with resulting scar 12. Previous tricuspid or mitral valve replacement or repair 13. Heart disease in which corrective surgery is anticipated within 6 months 14. Bleeding diathesis or suspected pro coagulant state 15. Contraindication to long term antithromboembolic therapy 16. Presence of any condition that precludes appropriate vascular access 17. Renal failure requiring dialysis 18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 19. Contraindication to computed tomography and magnetic resonance angiography 20. Severe 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 severe chronic symptoms 21. Positive pregnancy test results for female patients of childbearing potential 22. Patient has other anatomic or co morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results 23. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this study 24. Patient is unlikely to survive the protocol follow up period of 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) | 12 Months post ablation | Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period. |
| Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event | 7 days | The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal. |
Countries
United States
Participant flow
Recruitment details
109 subjects were directly enrolled into the TactiCath PAS 50 subjects rolled over from the TactiCath Continued Access Protocol 19 subjects rolled over from the TOCCASTAR Supplemental Study The first subject was enrolled on January 21, 2015 and the last subject on January 29, 2016. All enrollment was from sites within the United States.
Pre-assignment details
Only subjects that met all inclusion criteria and did not meet any exclusion criteria were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| TactiCath Quartz Ablation with TactiCath Quartz | 178 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrollment closure | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Unapproved ablation operator | 1 |
| Overall Study | Visit compliance | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | TactiCath Quartz |
|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 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 | 3 Participants |
| Race (NIH/OMB) White | 172 Participants |
| Region of Enrollment United States | 178 participants |
| Sex: Female, Male Sex Female | 73 Participants |
| Sex: Female, Male Sex Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 173 |
| other Total, other adverse events | 30 / 173 |
| serious Total, serious adverse events | 14 / 173 |
Outcome results
Primary
Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event
The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.
Time frame: 7 days
Population: The analysis population includes all subjects in whom a study device was introduced.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath Quartz | Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event | 14 Participants |
Comparison: H0: PS ≥ 16.2% Ha: PS \< 16.2% where PS is the primary safety endpoint ratep-value: 0.0013Exact binomial
Primary
Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)
Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.
Time frame: 12 Months post ablation
Population: Subjects who terminated the study prematurely before experiencing a treatment failure were not considered a treatment success at 12-months. Subjects who terminated the study for reasons clearly unrelated to the study device were also excluded and not considered treatment failures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath Quartz | Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) | 111 Participants |
Comparison: H0: PE ≤ 54.9% Ha: PE \> 54.9% Where PE is the primary effectiveness endpoint rate.p-value: 0.0008Exact binomial