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

NCT ID: NCT01032317

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Ischemic Ventricular Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-arm Study

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.

Group Type OTHER

Radiofrequency Catheter Ablation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion Criteria

* Longstanding persistent AF
* Idiopathic VT
* Congestive Heart Failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biosense Webster, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IKEM

Prague, , Czechia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EZCF-125

Identifier Type: -

Identifier Source: org_study_id