New Research Grant Support Opportunity

Purpose

Gore is interested in providing research grant support for independent research for healthcare professionals in the United States who are involved in the diagnosis and treatment of patients with iatrogenic atrial septal defects (iASDs). Funds will be made available to investigators with proposals that are focused on studying the clinical effects and potential implications of an iASD and how to tailor patient care. Gore is committed to supporting independent research activities that foster an increased understanding of scientific, clinical, or healthcare issues, and that serve to improve presentation of available care to appropriate patients at the right time for specific therapeutic areas. Approval of grant funding is not related to or conditioned upon purchases of Gore’s products or their recommendation. 

Research Needs

An iASD is a defect created or acquired when a catheter is put across the atrial septum, primarily in the ostium secundum region of the septum, to perform certain left-heart diagnostic or interventional procedures, such as ablation, left atrial appendage occlusion, and mitral valve repair or replacement (Kadado 2021, Nagy 2019). Once all catheters are removed, the resulting defect in the septum may allow blood to shunt between the left and right atria, either in left-to-right or right-to-left directions. In some patients this shunting can be clinically relevant, causing right heart volume overload or reduced systemic oxygenation (Takaya 2022, Kelly 2017, Nadkeolyar 2020). In many patients the iASD may close on its own over time or have clinically insignificant shunting (Lurz 2021). Clinical studies have shown that larger iASDs are more likely to remain open and cause residual shunting (Alkhouli 2016).

There are no established clinical guidelines on how to manage iASDs or when closure is recommended. Physicians should carefully monitor patients with iASDs and consider the hemodynamic impact of the shunt and clinical presentation when deciding on the necessity and timing of closure.  The decision to close an iASD is at the discretion of a patient’s physician based on patient-specific factors. Data on the clinical outcomes following creation of interatrial shunts suggest that some patients may benefit from the presence of an iASD and closing it may contribute to patient harm (Nanayakkara 2023; Hoffmann 2014).  Clinical studies of transcatheter edge-to-edge repair of the mitral valve, which have a 22 Fr delivery system that crosses the atrial septum, have demonstrated that 0-50% of patients will have a persistent iASD following the index procedure at timepoints up to 6 months post-procedure (Alkhouli 2016; Schueler 2015). In some cases, patients may have clinical signs that would suggest a benefit from closure including larger defects with left-to-right shunting that puts significant volumetric load on the right heart, right-to-left shunting resulting in hypoxemia, and a potential concern for paradoxical embolism (Wiktor et al 2018). 
Additional research regarding the clinical implications of iASDs after left-heart procedures would be valuable to the medical community. 

Research topics could include:

• The occurrence and natural medical course of iASDs
• The effect of iASDs on safety and effectiveness of the left-sided procedure completed
• The flow properties and hemodynamic effects of an iASD before and/or after necessary closure
• Data collection on the outcomes of left-sided procedures with and without iASD closure
• The characteristics of iASDs and patient demographics that predict clinical significance of the iASD 

Strengthening the evidence supporting proper treatment regimens for patients with an iASD will support medical practice. Research helping to unveil how to identify patients with an iASD that would or would not benefit from closure will be valuable to practitioners and help improve patient care and outcomes. As left-heart procedures are becoming more prevalent, the population of patients with iASDs will also increase. Research objectives focused on studying the clinical significance of iASDs will ultimately benefit the growing patient population.  

Activity Design

Please submit your concept proposal via our Portal or to the Grants Program Coordinator (Grants_Program@wlgore.com, +1 623-234-5521).

Outcomes Measurement 

The main goal of this request for research is to study and better understand the clinical significance of iASDs following left-sided heart interventional procedures. Producing evidence-based research that helps to understand the medical course of iASDs and how they affect patient outcomes can support clinical decision making and proper course of treatment for patients. Research proposals should be closely aligned with the research topics listed in the Research Needs section of this request and may focus on uncovering the question of who should and should not have an iASD closed. 

Terms and Conditions 

We reserve the right to approve or deny any or all applications received as a result of this request or to cancel, in part or in its entirety, this request for grants.  Gore is not responsible for any costs associated with a grant application.