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

Phase 1

Completed

• Conditions: Atrial Fibrillation; Ischemic Ventricular Tachycardia
• Interventions: Device: Radiofrequency Catheter Ablation

• Registration Number: NCT01032317
• Lead Sponsor: Biosense Webster, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-13
• Study First Posted: 2009-12-15
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion Criteria

• Longstanding persistent AF
• Idiopathic VT
• Congestive Heart Failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm Study	Radiofrequency Catheter Ablation	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.

Primary Outcome Measures

Name	Time	Method
The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.	7 days	The primary safety endpoint is the incidence of early onset primary adverse events.

Trial Locations

Locations (1)

IKEM; 🇨🇿 Prague, Czech Republic