Study Conclusion: The TactiSense IDE results through 30 days demonstrate that the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is safe and effective for the treatment of paroxysmal atrial fibrillation.
(TactiSense IDE study. TactiCath SE IFU #ARTEN600049107 A, 2018-09.)
The observed rate of primary safety endpoint events was 4.7% (one-sided 95% upper confidence limit: 8.64%) and was statistically significantly lower than the predetermined performance goal of 16.2% (p<0.0001) for the TactiCath Contact Force Ablation Catheter, Sensor Enabled.
| Primary Safety Endpoint (SAF population) | Tacticath SE (N=149) | Upper One-sided 95% CL | Performace Goal1 | P-value2 |
|---|---|---|---|---|
| Subject experienced primary safety endpoint event (Device or procedure-related primary SAE) | 7 (4.7%) | (8.64%) | 16.2% | <0.0001 |
1 One-sided upper 95% confidence limit by Clopper Pearson Method.
2 One-sided p-value by using Binomial Exact Test against the performance goal of 16.2%, to be compared with one-sided significance level of 0.05.
| TactiSense IDE Primary Safety Endpoint Events (SAF population) | N (%) Subjects, N=149 |
|---|---|
| Atrial-esophageal fistula | 1 (0.7%) |
| AV block | 0 (0.0%) |
| Cardiac perforation/tamponade | 3 (2.0%) |
| Death | 0 (0.0%) |
| Diaphragmatic paralysis | 0 (0.0%) |
| Gastroparesis | 0 (0.0%) |
| Hospitalization | 0 (0.0%) |
| Myocardial Infarction | 0 (0.0%) |
| Pericarditis | 1 (0.7%) |
| Pneumothorax | 0 (0.0%) |
| Pulmonary edema | 0 (0.0%) |
| Pulmonary vein stenosis | 0 (0.0%) |
| Stroke | 0 (0.0%) |
| Thromboembolism | 1 (0.7%) |
| Transient ischemic attack | 0 (0.0%) |
| Vascular Access Complication | 2 (1.3%) |
| Total Device or Procedure-related Primary SAEs | 0 (0.0%) |
Acute procedural success was achieved in 98.0% (148/151) subjects who had the TactiCath Contact Force Ablation Catheter, Sensor Enabled inserted into the vasculature. The lower bound of the one-sided 95% confidence interval was 94.95%, which is greater than the performance goal of 90%. Therefore, the null hypothesis was rejected and the primary effectiveness endpoint passed.
| Primary Effectiveness Endpoint (EFF population) | Tacticath SE (N=151) | Lower One-sided 95% CL1 | Performace Goal | P-value2 |
|---|---|---|---|---|
| Acute Procedure Success* | 98.0 (148/151) | 94.95% | 90% | 0.0001 |
1One-sided lower 95% confidence limit by Clopper Pearson Method.
2One-sided p-value by using Binomial Exact Test against the performance goal of 90%, to be compared with one-sided significance level of 0.05.
*The primary effectiveness endpoint was acute procedure success, defined as confirmation of entrance block at least 30 minutes after the last ablation in each pulmonary vein.
| TactiSense IDE Descriptive Endpoints Procedural Characteristics | (EFF Population) Total N=150 |
|---|---|
| Was the recommended power of 10-30W used? (% Yes) | 58.7% (88/150) |
| Average RF power (W) | Median (Q1, Q3): 29.0 (26.0, 32.0) (n=149) |
| Average contact force (g) per subject | Mean ± SD: 12.1 ± 4.7 Median (Q1, Q3): 11.2 (8.5, 14.3) Range (min, max): (5.0, 32.0) (n = 149) |
| % of patients achieving ≥ 90% lesions with ≥10 g contact force | 3.4% (5/149) |
| Total procedure time (min) | Median (Q1, Q3): 159.5 (123.0, 206.0) (n=150) |
| Total RF time (entire case in min) | Median (Q1, Q3): 35.7 (28.9, 51.9) (n=149) |
| Fluoroscopy time (min) | Median (Q1, Q3): 9.0 (5.0, 16.0) (n=150) |
| AutoMark turned on for procedure? (Yes) | 99.3% (149/150) |
| Was AutoMark used to guide therapy? (Yes) | 92.6% (125/135) |
1 TactiSense IDE study. TactiCath SE IFU #ARTEN600049107 A, 2018-09.
*Effortless handling is based on how physicians scored catheter handling characteristics during an initial market release.
MAT-2013028 v1.0
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