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:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01032317
First received: December 11, 2009
Last updated: September 8, 2011
Last verified: September 2011
  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: 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 ] [ Designated as safety issue: Yes ]
    The primary safety endpoint is the incidence of early onset primary adverse events.


Estimated Enrollment: 40
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032317

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

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01032317     History of Changes
Other Study ID Numbers: EZCF-125
Study First Received: December 11, 2009
Last Updated: September 8, 2011
Health Authority: Czech Republic: State Institute for Drug Control

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

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

ClinicalTrials.gov processed this record on April 14, 2014