Foresight Intracardiac Echocardiography (ICE) System

Early Phase 1

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Foresight ICE System

• Registration Number: NCT02514876
• Lead Sponsor: Conavi

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-08-01
• Study First Posted: 2015-08-04
• Study Start: 2015-09
• Primary Completion: 2016-04-08
• Study Completion: 2016-05-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm- Foresight ICE System	Foresight ICE System	This open label feasibility study will evaluate the Foresight ICE system for imaging chambers of the heart and guiding transseptal puncture during an atrial fibrillation (AF) ablation procedure.

Primary Outcome Measures

Name	Time	Method
Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device	During ablation procedure (2-4 h)

Trial Locations

Locations (1)

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada