SmartTouch Catheter for Left Anterior Line - SmarT Line Study

Study Overview
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Brief Summary
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This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.

Detailed Description
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Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF). The three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions. The ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.

Official Title
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Bidirectional Conduction Block of Left Atrial Anterior Line in Patients With Left Atrial Ablation - Reduction of RF Applications Using the Thermocool SmartTouch Contact Force Sensing Catheter

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Thermocool Smart Touch Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter Patients with persistent atrial fibrillation Patients with perimitral flutter Patients with recurrence after a circumferential PV isolation procedure Patients with paroxysmal atrial fibrillation and AF episodes lasting > 7 days Patients (>18 und <80 Jahre) Exclusion Criteria: moderate to severe valvular heart disease, congenital heart disease reduced left ventricular function (ejection fraction <35%) any reversible cause for atrial fibrillation (e.g. hyperthyroidism) intracardiac thrombi documented by transesophageal echocardiography myocardial infarction within 3 months, cardiac surgery in the previous three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: operator informed to contact force<br>Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster) | Device: Thermocool Smart Touch Catheter<br>* Physician informed to contact force<br>|
| Experimental: operator blinded to contact force<br>Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster) | Device: Thermocool Smart Touch Catheter<br>* Physician informed to contact force<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes) |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of primary endpoint (bidirectional conduction block at an anterior line) | Achievement of primary endpoint (bidirectional conduction block at an anterior line). Procedure Duration. Reduction of local potential amplitude during SR or atrial fibrillation after 60 seconds of ablation. Freedom of any atrial tachyarrhythmia at 7 day holter 3 and 6 months after a single ablation procedure. Freedom of any symptoms of atrial arrhythmias 6 months after ablation (except during blanking period of 6 weeks). Confirmation of gap-freeness in MRI (3-6 months after ablation). Quality of Life (atrial fibrillation symptom checklist und major depression index) pre, 3 and 6 months after Ablation. Safety (bleeding, pericardial effusion, thrombembolic events). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smart-Touch, Contact force