Title:  The Feasibility of Using Real-World Data in the Evaluation of Cardiac Ablation Catheters

Technology of Interest:  Ablation Catheters

Disease Area:  Cardiology

Duration:  8 months

Network Collaborator(s):  Mercy; Mayo Clinic; Yale-New Haven Hospital

This test-case will assess the ability of the NESTcc Data Network to reliably and validly capture data on class III surgical devices to study the safety and effectiveness outcomes for an indication expansion.
Currently, the standard treatment for cardiac arrhythmias includes cardiac ablation with a catheter to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Catheters have been generally approved by the FDA for use in the treatment of specific cardiac arrhythmias, such as paroxysmal atrial fibrillation and ischemic ventricular tachycardia. Catheters vary in which of these cardiac arrhythmias the FDA has approved their use. There are currently no catheters that are indicated for the treatment of persistent atrial fibrillation.
This test-case will explore the feasibility of generating evidence for label expansions on the use of cardiac ablation catheters to treat cardiac arrhythmias. The feasibility assessment will examine if the NESTcc Data Network Collaborators capture the necessary data elements, and if the data are of appropriate quality (e.g., reliability and relevance) and there is a sufficient population for a representative sample to support a robust and rigorous study for label extensions.

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Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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