TactiCath

Indications:

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.

Contraindications:

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.

TactiCath Contact Force Ablation Catheter, Sensor Enabled Clinical Evidence

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.

Highlights from TactiSense IDE Study⁴

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).

• 4.7% observed rate of primary safety endpoint events (one-sided 95% upper confidence limit: 8.64%)⁴
• 98% of subjects who had the TactiCath Contact Force Ablation Catheter, Sensor Enabled inserted into the vasculature achieved acute procedural success. The null hypothesis was rejected and the primary effectiveness endpoint passed, since the lower bound of the one-sided 95% confidence interval was 94.95%, which was greater than the 90% performance goal.⁴

*Effortless handling is based on how physicians scored catheter handling characteristics during an initial market release.

References

1. Abbott. Data on File. Report 90430651.
2. Abbott. Data on File. Report 90349982.
3. Abbott. Data on File. Report 90214738.
4. Abbott. Data on File. Report 90253949.