TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
It has been hypothesized that the ability to create durable lesions during radiofrequency (RF) ablation is directly correlated with a reduction in the recurrence of arrhythmia in patients with paroxysmal atrial fibrillation (PAF). Lesion depth is directly correlated with the contact force measured between the the tip of the catheter and the heart tissue. In this study, patients in whom a pulmonary vein isolation procedure has been prescribed for the treatment of PAF will be randomized for treatment with either a device incorporating contact force sensing or one without. To be included in the study, patients 18 or older must demonstrate a history of atrial fibrillation and will have failed treatment using antiarrhythmic medications. In both study arms, ablation will be performed using an accepted treatment strategy and standard procedures. Patients will receive routine follow-up for 12 months after the procedure, with the addition of ambulatory monitoring to detect the recurrence of episodes of atrial arrhythmia. The study will compare the effectiveness of the procedure in the two arms, and will characterize any differences in safety outcomes primarily related to complications arising from the use of an ablation device and the ablation procedure.

Official Title
-----------------
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Catheter ablation to treat paroxysmal atrial fibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TactiCath<br>Catheter ablation to treat paroxysmal AF using the TactiCath catheter with contact force capability | Device: Catheter ablation to treat paroxysmal atrial fibrillation<br>* A pulmonary vein isolation procedure will be performed using radiofrequency ablation.<br>|
| Active Comparator: Control<br>Catheter ablation to treat paroxysmal AF using a catheter with no contact force sensing capability | Device: Catheter ablation to treat paroxysmal atrial fibrillation<br>* A pulmonary vein isolation procedure will be performed using radiofrequency ablation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure. | 12 months | 
| Incidence of Device-related Early-onset Primary Serious Adverse Events | Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RF, paroxysmal atrial fibrillation, atrial fibrillation, radiofrequency ablation, pulmonary vein isolation, ablation catheter, contact force sensing, contact force, contact force assisted ablation