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.|
|ClinicalTrials.gov Identifier: NCT01032317|
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 4, 2014
|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)|
|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|
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.
- 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.
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
|Prague, Czech Republic|