Status:
COMPLETED
Foresight Intracardiac Echocardiography System (ICE)
Lead Sponsor:
Conavi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 procedur...
Detailed Description
The study will recruit 10 patients at a single center.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03239444
Start Date
April 24 2017
End Date
December 24 2018
Last Update
July 23 2019
Active Locations (1)
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1
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y2P6