Clinical trial NCT04704791: Surgical PA-LAA Shunting: a Feasibility Study
Official title: Surgical PA-LAA Shunting for Management of Systemic Embolization in Patients With Atrial Fibrillation: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: LAA Thrombus Prevention
Keywords: shunting
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years undergoing CV surgery
* History of AF with a CHADS2 score \>1
* Relative contraindication to OAC as determined by the heart team

  1. Dialysis or preoperative eGFR of \<15
  2. Bleeding on DOAC/Coumadin with non-reversible pathology
  3. 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 Criteria:

* 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

Primary outcomes:
measure: Composite of device safety and performance
timeFrame: 3 months
Secondary outcomes:
measure: Device related performance - maintaining patency
timeFrame: 1 year
measure: Systemic embolization
timeFrame: 1 year
measure: Systemic saturations
timeFrame: 1 year
measure: Need for intervention to close the shunt
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Benjamin Hibbert, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: