NCT04704791

Surgical PA-LAA Shunting: a Feasibility Study

Surgical PA-LAA Shunting for Management of Systemic Embolization in Patients With Atrial Fibrillation: a Feasibility Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 form is cut out. Surgically cutting out the left atrial appendage can be difficult and complications can occur. An alternative strategy is to create a tunnel to increase blood flow and wash out the part of the heart where clots form. This strategy has not been previously studied. The purpose of this study is to determine if creating a tunnel to increase blood flow is feasible and safe.

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 demonstrates that the anatomy of the LAA results in decreased velocities in the LAA apex. Introduction of a 3-4mm shunt in the apex can result in increased velocity, less stasis and a lower propensity for thrombus formation. Small (\<8mm) inter-chamber shunts can exist in humans with no long term hemodynamic consequences in otherwise structurally normal hearts - making a strategy of pulmonary artery (PA) to LAA shunt an attractive potential therapy given anatomic proximity and gradient differential between the cardiac chambers. This will be a 5 patient first-in-human feasibility study. The population will include patients undergoing CABG or other cardiovascular surgery with AF and a CHADS2 score \>1 in whom the treating team deems traditional therapy with anticoagulants is prohibitive or ineffective (dialysis or EGFR preoperatively \<15, previous bleeding with non-reversible pathology, clinically deemed contraindicated to oral anticoagulant). The intervention will be PA-LAA shunt creation at the time of surgery. As this is a single arm study there will be no comparison group.

Conditions

• LAA Thrombus Prevention

Interventions

Type	Name	Description
PROCEDURE	PA-LAA shunt	At the time of surgery a covered stent will be inserted through the atriotomy into the left pulmonary artery and balloon dilated to stabilize the device. The target shunt diameter will be 3.5-4 mm to minimize LAA stasis.

Timeline

• Start date: 2021-03-19
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2021-01-12
• Last updated: 2022-10-12

Locations

1 site across 1 country: Canada