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

EZ Steer™ THERMOCOOL® With CF Sensing Capability (THERMOCOOL SMARTTOUCH™) for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01032317

Acronym

EZCF-125

Enrollment

Registered

2009-12-15

Start date

2009-11-30

Completion date

2010-11-30

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Ischemic Ventricular Tachycardia

Keywords

Arrhythmia, Electrophysiology, Fibrillation, Tachycardia, Ablation, Atrial Fibrillation (AF), Ischemic Ventricular Tachycardia (VT)

Brief summary

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.

Interventions

DEVICERadiofrequency Catheter Ablation

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion criteria

* Longstanding persistent AF * Idiopathic VT * Congestive Heart Failure

Design outcomes

Primary

Measure	Time frame	Description
The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.	7 days	The primary safety endpoint is the incidence of early onset primary adverse events.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026