Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia (EZCF-125)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01032317
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
Biosense Webster, Inc.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Ischemic Ventricular Tachycardia Device: Radiofrequency Catheter Ablation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EZ Steer™ THERMOCOOL® With CF Sensing Capability (THERMOCOOL SMARTTOUCH™) for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
Study Start Date : November 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Single-arm Study
This study was completed prior to the implementation of the requirement for specific identification of study arms. As the requirement was not made retroactive to completed studies, we believe this study to be exempt from the stipulation. Also, per PRS definition, since this is for a single-arm/feasibility study, the data elements are optional.
Device: Radiofrequency 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.

Primary Outcome Measures :
  1. The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events. [ Time Frame: 7 days ]
    The primary safety endpoint is the incidence of early onset primary adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion Criteria:

  • Longstanding persistent AF
  • Idiopathic VT
  • Congestive Heart Failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01032317

Czech Republic
Prague, Czech Republic
Sponsors and Collaborators
Biosense Webster, Inc.

Responsible Party: Biosense Webster, Inc. Identifier: NCT01032317     History of Changes
Other Study ID Numbers: EZCF-125
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation (AF)
Ischemic Ventricular Tachycardia (VT)

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes