Foresight Intracardiac Echocardiography System (ICE)

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: NCT03239444
• Other study ID #: EXT-001-1.5
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2017
• Est. completion date: December 24, 2018

Study information

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

Clinical Trial Summary

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.

Description:

The study will recruit 10 patients at a single center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 24, 2018
• Est. primary completion date: December 24, 2018
• 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/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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Intracardiac echocardiography imaging
Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.

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	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	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.