Status:
WITHDRAWN
Surgical PA-LAA Shunting: a Feasibility Study
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
LAA Thrombus Prevention
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial fibrillation is common and increases the risk of stroke. Traditionally patients are treated with blood thinning medications or at the time of surgery the part of the heart where blood clots for...
Detailed Description
The goal is to understand the potential avenues to increase Left Atrial Appendage (LAA) flow in patients with Atrial Fibrillation (AF) to minimize systemic embolization risk. Flow modeling demonstrate...
Eligibility Criteria
Inclusion
- Age ≥ 18 years undergoing CV surgery
- History of AF with a CHADS2 score \>1
- Relative contraindication to OAC as determined by the heart team
- Dialysis or preoperative eGFR of \<15
- Bleeding on DOAC/Coumadin with non-reversible pathology
- Other medical condition that makes the patient ineligible for OAC
- Anatomic proximity of LAA and PA on preoperative CT scan suitable for shunt creation
Exclusion
- LVEF \<40%
- History of VTE - either DVT or PE
- Resting baseline preoperative O2 sats \<98%
- Inability of the patient to provide written informed consent
- Greater than moderate valvular heart disease which is not to be addressed during surgical intervention
- Documented mPA to PCWP \<5mmHg
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04704791
Start Date
March 19 2021
End Date
December 15 2021
Last Update
October 12 2022
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7