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

This Test-Case assessed the ability of the NESTcc Research 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 project explored the feasibility of generating evidence for label expansions on the use of cardiac ablation catheters to treat cardiac arrhythmias. The feasibility assessment examined if the NESTcc Network Collaborators captured the necessary data elements, if the data were of appropriate quality (e.g., reliability and relevance), and if there was a sufficient population for a representative sample to support a robust and rigorous study for label extensions.