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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130026 / PAS001 |
| Date Original Protocol Accepted |
08/20/2014
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| Date Current Protocol Accepted |
08/20/2014
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| Study Name |
TactiCath Quartz PAS
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| Device Name |
TACTICATH QUARTZ SET
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| Clinical Trial Number(s) |
NCT01278953
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, non-randomized, multicenter, cohort
study which will combine new enrollments with patients currently enrolled in the TOCCASTAR supplemental IDE study (G100230/S014) and/or CAP study (G100230/S020) that are still active in the follow-up phase.
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| Sample Size |
A target of approximately 175 patients will be enrolled from
35 sites in the United States.
For the safety endpoint, a performance goal of 16.2% is proposed, equal to the rate of 8.1% plus a margin of 8.1%. Based on this performance goal, with a one-sided 0.05 alpha level, a total of 175 subjects would provide greater than 95% power for this endpoint on a one sample exact test of binomial proportions.
For the efficacy endpoint, a performance goal of 54.9% is proposed, equal to the lower quartile 64.9% minus a 10% margin. Based on this performance goal, with a one-sided
0.05 alpha level, a total of 175 subjects would provide approximately 80% power for an assumed event rate of 64.9% on a one sample exact test of binomial proportions.
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| Key Study Endpoints |
performance goal of 54.9%. Procedural failure is defined by
the occurrence of any of the following events:
1. Documentation of recurrence of AF/AFL/AT episodes during the 9-month observational period lasting longer than 30 seconds
2. Repeat ablation following the blanking period
3. Use of a new antiarrhythmic drug (AAD) following the blanking period (use of a previously ineffective drug does not constitute treatment failure)
Secondary endpoints
1. Recurrence of symptomatic AF at 5 years
2. Number of repeat ablations (incidence and time from index procedure)
3. Use of antiarrhythmic drugs
Primary endpoints
Safety
The rate of device or procedure related serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, is lower than a performance goal of 16.2%.
Effectiveness
The 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 is higher than a
4. Long-term (5 year) occurrence of Serious Adverse
Events (SAEs)
5. Device malfunction
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| Follow-up Visits and Length of Follow-up |
Duration of Study Participation:
Enrollment period: 18 months.
Patients will be evaluated at pre discharge, at 7 days, at 3, 6 and 12 months post index procedure and then yearly thereafter through 60 months.
After the index procedure, patients will be followed for a total of 60 months.
Total Study Duration: Up to 78 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
178 subjects enrolled, 173 evaluable subjects
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| Actual Number of Sites Enrolled |
20
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| Patient Follow-up Rate |
The overall follow-up rate is 43.8% (78/178) at 60-months. Follow-up rates were 69.7% (124/178) and 70.7% (126/178) at 48-month and 36-month follow-up, respectively. Out of the initial 178 enrolled subject, 56 subjects withdrew during the 60-month follow-up period.
The final visit cut-off date was October 5, 2020. 78 out of the expected 93 subjects completed the 60-month follow-up visit. The remaining 15 subjects were not able to complete their 60-month follow-up due to the cut-off date. 33 out of 56 subjects voluntarily withdrew. 29 subjects were considered withdrawn from trial prior to 60-month follow-up given that visit windows were not open prior to early termination of the trial on October 5, 2020.
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| Final Safety Findings |
8.7% (15/173) of subjects experienced a device or procedure related serious adverse event occurring within 7 days of the index procedure or hospital discharge (whichever is later), which met the primary safety endpoint performance goal (PG) of 16.2%. The most common primary serious adverse events (PSAE) were hospitalizations (3.5%, 6/173), vascular access complications (2.9%, 5/173) and cardiac perforation/tamponade (2.3%, 4/173). A total of 80 events that occurred in 45 subjects (26.0%, 45/173) were adjudicated as serious adverse events (SAEs) over the 5-year study period. 23 SAEs were reported as procedure related and 9 SAEs were device related. There were no deaths or unanticipated adverse events.
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| Final Effect Findings |
The proportion of patients free symptomatic recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia that lasted longer than 30 seconds through 12-months was 73.9% (122/165) [lower bound of 95% CI: 67.7%]. The proportion of patients free from symptomatic and asymptomatic AF/AFL/AT recurrence that lasted more than 30 seconds through 12-months was 66.1% (109/165) [lower bound of 95% CI: 59.5%]. The
primary effectiveness endpoint PG of 54.9% at 12-months after exclusion of a 3-month blanking period was met.
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| Study Strengths & Weaknesses |
Strengths: The TactiCath Quartz PAS evaluated 5-year long term safety and effectiveness of the device. The primary endpoints performance goals were met.
Weakness: There was significant number of subjects lost to follow-up over the 60-month period. However, 33 subjects were withdrawal of consent and 29 were lost due to early termination of the study at the cut-off date of October 5, 2020.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term data from the TactiCath Quartz PAS. The labeling should include a new section in the instructions for use for the TactiCath Contact Force, Sensor Enabled catheter, which provides a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow-up visits, etc.), final results, study strengths and limitations of the PAS.
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