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Completed

NCT Number: NCT03239444

Foresight Intracardiac Echocardiography System (ICE)

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y2P6, Canada

About this study

The study will recruit 10 patients at a single center.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracardiac echocardiography imaging

Device

Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.

Primary outcomes

  1. 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.

    Time frame: For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.

    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).

Secondary outcomes

  1. Collection of first human images with Conavi's Foresight System.

    Time frame: An individual physician satisfaction survey will be completed for each case on the day of the procedure.

    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.

Sponsors and collaborators

Lead sponsor

Conavi

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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