NCT03239444

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 atrial-fibrillation

Timeline
Completed

Started Apr 2017

Typical duration for phase_1 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2018

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2017

Enrollment Period

1.7 years

First QC Date

July 24, 2017

Last Update Submit

July 22, 2019

Conditions

Atrial Fibrillation

Keywords

ICEAblationTrans-septalSeptumEchocardiography

Outcome Measures

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.

    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 Outcomes (1)

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

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

Study Arms (1)

Assigned Intervention

OTHER

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. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure.

Device: Intracardiac echocardiography imaging

Interventions

Intracardiac echocardiography imagingDEVICE

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

Assigned Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y2P6, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Atul Verma, MD

    Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 4, 2017

Study Start

April 24, 2017

Primary Completion

December 24, 2018

Study Completion

December 24, 2018

Last Updated

July 23, 2019

Record last verified: 2017-07

Locations

CA(1)