Foresight Intracardiac Echocardiography System (ICE)

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

This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Intracardiac echocardiography imaging

Detailed Description

The study will recruit 10 patients at a single center.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y2P6
      • Southlake Regional Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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/study investigator 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Assigned Intervention; Device: Foresight ICE System The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird console. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure.	Device: Intracardiac echocardiography imaging; Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation.	The ability of the study device to identify the atrial septum during transseptal puncture will be evaluated by the physician on the day of the procedure and captured in the individual case report form. This will be based on the objective finding of whether the transseptal puncture was performed (Yes or No) under study device guidance. This information will be gathered for each patient in the individual case report form and presented qualitatively and as quantitative measures (percentage success).	For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of first human images with Conavi's Foresight System.	The Conavi's Foresight System will be utilized to capture images of relevant human cardiac anatomical landmarks (e.g. crista terminalis, tricuspid valve, coronary sinus) while the catheter will be manipulated inside the heart during the procedure. The physician satisfaction survey will ask the physician to specifically tabulate structures that could be identified in a binary yes/no format. This kind of information will be gathered for each patient in the individual physician satisfaction surveys and presented qualitatively.	An individual physician satisfaction survey will be completed for each case on the day of the procedure.

Collaborators and Investigators

• Sponsor: Conavi
• Investigators: Principal Investigator: Atul Verma, MD, Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): December 24, 2018
• Study Completion (Actual): December 24, 2018

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Ablation; Echocardiography; ICE; Trans-septal; Septum
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: EXT-001-1.5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No