Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia (EZCF-125)

Biosense Webster

Status and phase: Completed; Phase 2; Phase 1

Conditions: Atrial Fibrillation; Ischemic Ventricular Tachycardia

Treatments: Device: Radiofrequency Catheter Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01032317

EZCF-125

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion criteria

• Longstanding persistent AF
• Idiopathic VT
• Congestive Heart Failure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Single-arm Study

Other group

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.

Treatment:

Device: Radiofrequency Catheter Ablation