Foresight Intracardiac Echocardiography (ICE) System

Conavi

Status and phase: Completed; Early Phase 1

Conditions: Atrial Fibrillation

Treatments: Device: Foresight ICE System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02514876

EXT-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single arm- Foresight ICE System

Experimental group

Description:

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.

Treatment:

Device: Foresight ICE System