TOCCATA - Touch+™ for Catheter Ablation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Atrial Fibrillation Tachycardia, Supraventricular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atrial Fibrillation

Group Type EXPERIMENTAL

Contact force assisted irrigated RF ablation

Intervention Type DEVICE

radiofrequency ablation of atrial fibrillation or SVT

Right-sided Supraventricular Tachycardia

Group Type EXPERIMENTAL

Contact force assisted irrigated RF ablation

Intervention Type DEVICE

radiofrequency ablation of atrial fibrillation or SVT

Interventions

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Contact force assisted irrigated RF ablation

radiofrequency ablation of atrial fibrillation or SVT

Intervention Type DEVICE

Other Intervention Names

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TactiCath® TactiSys®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No