Back to resultsForesight Intracardiac Echocardiography (ICE) System
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Foresight ICE System
Sponsored by
About this trial
This is an interventional device feasibility trial for Atrial Fibrillation
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 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
Experimental
Arm Label
Single arm- Foresight ICE System
Arm Description
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.
Outcomes
Primary Outcome Measures
Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02514876
Brief Title
Foresight Intracardiac Echocardiography (ICE) System
Official Title
Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 8, 2016 (Actual)
Study Completion Date
May 5, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conavi
4. Oversight
5. Study Description
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.
Detailed Description
This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm- Foresight ICE System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Foresight ICE System
Intervention Description
The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console.
Primary Outcome Measure Information:
Title
Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
Time Frame
During ablation procedure (2-4 h)
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 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 Centre
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
Learn more about this trial
Foresight Intracardiac Echocardiography (ICE) System
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