SmartTouch Catheter for Left Anterior Line

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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operator informed to contact force

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

Group Type ACTIVE_COMPARATOR

Thermocool Smart Touch Catheter

Intervention Type DEVICE

Physician informed to contact force

operator blinded to contact force

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

Group Type EXPERIMENTAL

Thermocool Smart Touch Catheter

Intervention Type DEVICE

Physician informed to contact force

Interventions

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Thermocool Smart Touch Catheter

Physician informed to contact force

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No