TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is an innovative ablation solution for the treatment of atrial fibrillation. Featuring advanced handle-shaft technology, the TactiCath Contact Force Ablation Catheter, Sensor Enabled fully integrates with Abbott’s EnSite Precision™ cardiac mapping system.
TactiCath Contact Force Ablation Catheter, Sensor Enabled offers high accuracy1, effortless handling2,* and automated guidance.3
The TactiCath Contact Force Ablation Catheter, Sensor Enabled is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
Do not use for any of the following conditions: certain recent heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, or an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement.
Multiple clinical trials have evaluated the safety and effectiveness of the TactiCath Contact Force Ablation Catheter, Sensor Enabled. For a deep dive into the clinical data, visit the Clinical Evidence and Journal Article information.
The TactiSense IDE study was a prospective, multi‐center, single‐arm clinical trial that demonstrated the acute safety and effectiveness of the TactiCath Contact Force Ablation Catheter, Sensor Enabled for treatment of paroxysmal atrial fibrillation (PAF).
|Primary Safety Endpoint (SAF population)||Tacticath SE (N=149)||Upper One-sided 95% CL||Performance Goal*||P-value**|
|Subject experienced primary safety endpoint event (Device or procedure-related primary SAE)||7 (4.7%)||(8.64%)||16.2%||<0.0001|
*One-sided upper 95% confidence limit by Clopper Pearson Method.
**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.
*Effortless handling is based on how physicians scored catheter handling characteristics during an initial market release.
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