SmartTouch Catheter for Left Anterior Line - SmarT Line Study

LMU Klinikum

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: Device: Thermocool Smart Touch Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02217657

MucM001-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

operator informed to contact force

Active Comparator group

Description:

Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)

Treatment:

Device: Thermocool Smart Touch Catheter

operator blinded to contact force

Experimental group

Description:

Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)

Treatment:

Device: Thermocool Smart Touch Catheter