Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

Atrial Fibrillation Clinical Trial

— EZCF-125  

Official title:

EZ Steer™ THERMOCOOL® With CF Sensing Capability (THERMOCOOL SMARTTOUCH™) for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032317
• Other study ID #: EZCF-125
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2009
• Last updated: December 2, 2014
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: December 2014
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion Criteria:

• Longstanding persistent AF

• Idiopathic VT

• Congestive Heart Failure

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemic Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	IKEM	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days	Yes