Foresight Intracardiac Echocardiography (ICE) System

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514876
• Other study ID #: EXT-001
• Status: Completed
• Phase: Early Phase 1
• First received: July 27, 2015
• Last updated: April 21, 2017
• Start date: September 2015
• Est. completion date: May 5, 2016

Study information

• Verified date: April 2017
• Source: Conavi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 5, 2016
• Est. primary completion date: April 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

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.

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Conavi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device		During ablation procedure (2-4 h)