Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center.

ABSTRACT:

Objectives

To determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.

Design

Retrospective cohort.

Setting

Three health systems in the USA.

Participants

Patients receiving ablation with the two ablation catheters of interest at any of the three health systems.

Main outcome measures

Feasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of int

SUBMITTER: Dhruva SS 

PROVIDER: S-EPMC8749235 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature