Back to resultsStudy of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia (EZCF-125)
Primary Purpose
Atrial Fibrillation, Ischemic Ventricular Tachycardia
Status
Completed
Phase
Phase 1
Locations
Czech Republic
Study Type
Interventional
Intervention
Radiofrequency Catheter Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Arrhythmia, Electrophysiology, Fibrillation, Tachycardia, Ablation, Atrial Fibrillation (AF), Ischemic Ventricular Tachycardia (VT)
Eligibility Criteria
Inclusion Criteria:
- Symptomatic atrial fibrillation or ischemic ventricular tachycardia
Exclusion Criteria:
- Longstanding persistent AF
- Idiopathic VT
- Congestive Heart Failure
Sites / Locations
- IKEM
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single-arm Study
Arm Description
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.
Outcomes
Primary Outcome Measures
The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.
The primary safety endpoint is the incidence of early onset primary adverse events.
Secondary Outcome Measures
Full Information
NCT ID
NCT01032317
First Posted
December 11, 2009
Last Updated
December 2, 2014
Sponsor
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01032317
Brief Title
Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
Acronym
EZCF-125
Official Title
EZ Steer™ THERMOCOOL® With CF Sensing Capability (THERMOCOOL SMARTTOUCH™) for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Ischemic Ventricular Tachycardia
Keywords
Arrhythmia, Electrophysiology, Fibrillation, Tachycardia, Ablation, Atrial Fibrillation (AF), Ischemic Ventricular Tachycardia (VT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm Study
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Radiofrequency Catheter Ablation
Intervention Description
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 Measure Information:
Title
The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.
Description
The primary safety endpoint is the incidence of early onset primary adverse events.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic atrial fibrillation or ischemic ventricular tachycardia
Exclusion Criteria:
Longstanding persistent AF
Idiopathic VT
Congestive Heart Failure
Facility Information:
Facility Name
IKEM
City
Prague
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
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