NCT02514876

CompletedEarly Phase 1

Foresight Intracardiac Echocardiography (ICE) System

Conavi Source

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Other study identifiers

Sponsor study identifier

EXT-001

Study Type

interventional

Actual enrollment (reported)

10

Locations

1 country

Sites

1

Timeline

Study Start

September 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 8, 2016

Actual (reported)

Study Completion

May 5, 2016

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 10 participants
Study completion date: May 5, 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 27, 2015
Actual (reported)
First Posted
August 4, 2015
Actual (reported)
Study Start
September 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 8, 2016
Actual (reported)
Study Completion
May 5, 2016
Actual (reported)

Last Updated: April 24, 2017
Status Verified: April 2017
Last Update Submitted: April 21, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
During ablation procedure (2-4 h)

Study Arms (1)

Single arm- Foresight ICE System

EXPERIMENTAL

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.

Device: Foresight ICE System

Interventions

Foresight ICE SystemDevice

The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console.

Single arm- Foresight ICE System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

Conavi
Industrylead

Study Sites (1)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y2P6, Canada

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Atul Verma, MD
Southlake Health
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early 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 27, 2015

First Posted

August 4, 2015

Study Start

September 2015

Date type not reported

This date has not been verified as actual or estimated.

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Phase 4Terminated

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Not ApplicableUnknown

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Not ApplicableCompleted

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 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.

Primary Completion

April 8, 2016

Actual (reported)

Study Completion

May 5, 2016

Actual (reported)

Last Updated

April 24, 2017

Record last verified: 2017-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02514876
Data provider: ClinicalTrials.gov
Source updated: 2017-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:50 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Single arm- Foresight ICE System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations