Foresight Intracardiac Echocardiography (ICE) System

This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y2P6, Canada

About this study

This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient is at least 18 years old.
Patient is undergoing an atrial fibrillation ablation procedure.
Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
Patient provides informed, written consent for participation in the study.

Exclusion criteria

Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure).
Patients in whom transseptal puncture is relatively contraindicated.
Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
Women of child bearing potential, in whom pregnancy cannot be excluded.
Patients unable to grant informed, written consent for participation in the study.

Treatment and study plan

Foresight ICE System

Device

The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console.

Primary outcomes

Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device

Time frame: During ablation procedure (2-4 h)

Sponsors and collaborators

Lead sponsor

Conavi

Industry

Registry information

Official study title

Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 4, 2015
Registry last updated: Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed