TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Overview

About this study

The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied.

A second phase of the study will treat up to 50 non-randomized subjects with a new version of the device under the same protocol.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug
minimum one documented PAF episode >30 sec duration within prior 12 months
minimum three PAF episodes during prior 12 months
18 years or older

Exclusion Criteria:

persistent or long-standing persistent AF
four or more cardioversions in prior 12 months
MI, CABG or PCI within preceding 3 months
left atrial diameter > 5.0 cm
LVEF < 35%
NYHA class III or IV
previous left atrial ablation procedure
previous tricuspid or mitral valve repair surgery

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