Foresight Intracardiac Echocardiography (ICE) System
Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Sep 2015
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2015
CompletedFirst Posted
Study publicly available on registry
August 4, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2016
CompletedApril 24, 2017
April 1, 2017
7 months
July 27, 2015
April 21, 2017
Conditions
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
EXPERIMENTALThis 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.
Interventions
The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console.
Eligibility Criteria
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 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
- Conavilead
Study Sites (1)
Southlake Regional Health Centre
Newmarket, Ontario, L3Y2P6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Atul Verma, MD
Southlake Regional Health Centre
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 1, 2015
Primary Completion
April 8, 2016
Study Completion
May 5, 2016
Last Updated
April 24, 2017
Record last verified: 2017-04