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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032317
First Posted: December 15, 2009
Last Update Posted: December 4, 2014
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.
Information provided by (Responsible Party):
Biosense Webster, Inc.
  Purpose
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 Intervention Phase
Atrial Fibrillation Ischemic Ventricular Tachycardia Device: Radiofrequency Catheter Ablation Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion Criteria:

  • Longstanding persistent AF
  • Idiopathic VT
  • Congestive Heart Failure
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01032317


Locations
Czech Republic
IKEM
Prague, Czech Republic
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01032317     History of Changes
Other Study ID Numbers: EZCF-125
First Submitted: December 11, 2009
First Posted: December 15, 2009
Last Update Posted: December 4, 2014
Last Verified: December 2014

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

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