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%)|
|Diaphragmatic paralysis||0 (0.0%)|
|Myocardial Infarction||0 (0.0%)|
|Pulmonary edema||0 (0.0%)|
|Pulmonary vein stenosis||0 (0.0%)|
|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.