Comparing Electrophysiology-Guided and Standard Monitoring for New Left Bundle Branch Block After TAVI

What this Trial Is About

Researchers are evaluating a new monitoring strategy for patients who develop a new left bundle branch block LBBB after undergoing transcatheter aortic valve implantation TAVI. This study compares an electrophysiology-based algorithmic approach with the standard clinical follow-up using 30-day transcutaneous cardiac monitoring. The goal is to determine if the electrophysiology method better reduces the combined risk of syncope, hospitalization, and death in these patients. Participants who are 18 years or older and have no pacemaker will be randomly assigned to one of two groups. One group will have an electrophysiology study before hospital discharge and receive a pacemaker if certain electrical delays are detected. The other group will have at least 72 hours of ECG monitoring in hospital followed by 30 days of transcutaneous cardiac monitoring using a device that continuously records heart rhythms. During the study, participants will be monitored for cardiovascular hospitalizations, episodes of syncope, emergency visits, and death over 12 months. Researchers will also assess procedural complications, atrioventricular blocks, and cost-effectiveness of the electrophysiology-guided approach. The study involves regular evaluations and cardiac monitoring to track heart events and overall safety throughout the 12-month period.

Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI