Study of Remote 30-Day ECG Monitoring Versus Standard Care After Transcatheter Aortic Valve Replacement to Improve Heart Rhythm Management

What this Trial Is About

The DRAGON TAVI study is a multicenter, prospective, open, randomized trial focusing on patients with severe aortic stenosis who are at moderate or high cardiovascular risk and undergoing Transcatheter Aortic Valve Implantation TAVI. The trial aims to evaluate whether continuous remote ECG monitoring over 30 days can improve the detection and management of clinically significant atrio-ventricular block compared to standard care. This research is conducted by the Medical University of Silesia and will enroll 250 patients. Participants will be randomly assigned to one of two groups the study group will receive continuous 30-day ECG monitoring with follow-up visits triggered by ECG findings, while the control group will receive the standard postoperative ECG monitoring for 24 to 48 hours and a regular follow-up visit with a standard ECG within 30 days after TAVI. The study duration is approximately 12 months. During the study, researchers will assess the total incidence of clinically significant atrio-ventricular block within 30 days as the primary outcome. Secondary outcomes include all-cause mortality, major adverse cardiovascular events such as cardiovascular death, stroke, myocardial infarction, hospitalization for heart failure, episodes of syncope, and cardiac arrhythmias over a 24-month period. Participants will undergo ECG monitoring and follow-up visits as per their assigned group, with ongoing evaluations to track heart rhythm and related complications throughout the study period.

Remote ECG Monitoring Post TAVI