Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2017-04-24
2018-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Assigned Intervention
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.
Intracardiac echocardiography imaging
Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.
Interventions
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Intracardiac echocardiography imaging
Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Conavi
INDUSTRY
Responsible Party
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Principal Investigators
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Atul Verma, MD
Role: PRINCIPAL_INVESTIGATOR
Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6
Locations
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Southlake Regional Health Centre
Newmarket, Ontario, Canada
Countries
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Other Identifiers
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EXT-001-1.5
Identifier Type: -
Identifier Source: org_study_id
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