TOCCATA - Touch+™ for Catheter Ablation

A Prospective Safety, Performance and Preliminary Effectiveness, Multi-centre, Clinical Investigation Using the Irrigated TactiCath™ Percutaneous Ablation Catheter for the Treatment of Supra-Ventricular Tachyarrhythmia Using RF Ablation

The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.

Safety: The primary safety endpoint assesses the incidence of procedure or device related SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure.

Performance: The primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. The secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations.

Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters

Inclusion Criteria:

• Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia [AVNRT], accessory pathway Wolff Parkinson White [WPW] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation

Exclusion Criteria:

• Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery
• Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart
• Known cerebrovascular disease, including a history of stroke or transient ischemic attack
• Left ventricular ejection fraction of <35%
• Previous heart ablation procedure (surgical or catheter) to the target chamber