Back to resultsForesight Intracardiac Echocardiography System (ICE)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Intracardiac echocardiography imaging
Sponsored by
About this trial
This is an interventional device feasibility trial for Atrial Fibrillation focused on measuring ICE, Ablation, Trans-septal, Septum, Echocardiography
Eligibility Criteria
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.
Sites / Locations
- Southlake Regional Health Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Assigned Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03239444
Brief Title
Foresight Intracardiac Echocardiography System (ICE)
Official Title
Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
December 24, 2018 (Actual)
Study Completion Date
December 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conavi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
The study will recruit 10 patients at a single center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
ICE, Ablation, Trans-septal, Septum, Echocardiography
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assigned Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intracardiac echocardiography imaging
Intervention Description
Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.
Secondary Outcome Measure Information:
Title
Collection of first human images with Conavi's Foresight System.
Description
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.
Time Frame
An individual physician satisfaction survey will be completed for each case on the day of the procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Verma, MD
Organizational Affiliation
Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y2P6
Country
Canada
12. IPD Sharing Statement
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Foresight Intracardiac Echocardiography System (ICE)
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