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 |
1One-sided upper 95% confidence limit by Clopper Pearson Method.
2One-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.
TactiCath Contact Force Ablation Catheter, Sensor Enabled Clinical Study Summary
This summary describes two clinical studies: The TOCCASTAR clinical study is conducted for the TactiCath™ Set, which also supports the TactiCath™ Quartz Set. The TactiSense study is conducted to demonstrate the acute safety and effectiveness of ablation with the TactiCath Contact Force Ablation Catheter, Sensor Enabled, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
*Effortless handling is based on how physicians scored catheter handling characteristics during an initial market release.
MAT-2103109 v1.0
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