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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014