학술논문

Rationale and Design of the Robotic Transcatheter Ablation in Congenital Heart Disease (ROBOTIC) Registry : from the Pediatric and Congenital Electrophysiology Society (PACES) and the International Society for Adult Congenital Heart Disease (ISACHD).
Document Type
Article
Source
Journal of Atrial Fibrillation & Electrophysiology. Sep2022, Vol. 15 Issue 5, p72-78. 7p.
Subject
*CONGENITAL heart disease
*CATHETER ablation
*TECHNOLOGICAL innovations
*QUALITY of life
*PATIENTS' attitudes
Language
ISSN
2831-7335
Abstract
Background: Challenges to conventional ablation in patients with congenital heart disease are numerous and include vascular obstructions, massive chambers, distorted anatomies, baffles, conduits, patches, and prosthetic material. In certain circumstances, transcatheter punctures across conduits or patches may be deemed high risk and/or provide suboptimal access. Robotic magnetic-guided navigation systems overcome some limitations to manual catheter ablation by virtue of soft and flexible catheters steered from the tip, thereby allowing sharp and multiple angle trajectories. To date, magnetic-guided catheter ablation outcomes have not been systematically assessed in patients with congenital heart disease beyond single-center case series. Objectives: The primary objective of the ROBOtic Transcatheter ablation In Congenital heart disease (ROBOTIC) registry is to determine the safety and efficacy of magnetic-guided catheter ablation in patients with congenital heart disease. Additional objectives include assessing the impact on patient-reported outcomes and exploring factors associated with ablation failure. Study design: The ROBOTIC registry consists of two phases. Phase I will retrospectively enroll 400 patients with congenital heart disease of any age who have undergone magnetic-guided ablation at a participating site. Phase II will prospectively recruit 200 adults (=18 years) with congenital heart disease scheduled to undergo robotic magnetic-guided ablation. Recruitment will occur over a 4-year period, with a minimum follow-up of 1-year. The impact of robotic magnetic-guided ablation on patient-reported outcomes will be assessed by questionnaires on perceived health status, psychological functioning, quality of life, sense of coherence, illness perceptions, and catheter ablation-specific metrics. The study will be coordinated by the Montreal Health Innovations Coordinating Center (MHICC). [ABSTRACT FROM AUTHOR]