Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

Biosense Webster, Inc.22 enrolled

Overview

The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Ischemic Ventricular Tachycardia

Interventions

Radiofrequency Catheter AblationDEVICE

The Biosense Webster EZ Steer ThermoCool NAV Diagnostic / Ablation Deflectable Tip Catheter with Contact Force Sensing Capability is designed to facilitate electrophysiological mapping and transmit radiofrequency current as well as provide a real-time measurement of contact force.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic atrial fibrillation or ischemic ventricular tachycardia Exclusion Criteria: * Longstanding persistent AF * Idiopathic VT * Congestive Heart Failure

Locations (1)

IKEM

Prague, Czechia

Outcomes

Primary Outcomes

The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.

The primary safety endpoint is the incidence of early onset primary adverse events.

Time frame: 7 days

Data from ClinicalTrials.gov

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