Ambulatory Electrocardiographic Monitoring for Detecting High-Degree Atrio-Ventricular Block in Patients With New Persistent Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (MARE Study)

What this Trial Is About

Researchers are studying patients who undergo transcatheter aortic valve implantation (TAVI) and develop a new, persistent left bundle branch block (LBBB), a heart conduction problem. The study aims to find out how often and when serious types of atrioventricular block (AVB) occur in these patients and to identify predictors of this condition. They are also evaluating the use of the Reveal LINQae insertable cardiac monitor to detect important heart rhythm problems in this group. After TAVI, patients are monitored with ECG during their hospital stay, with daily ECGs until discharge. Those with persistent new-onset LBBB lasting at least 48 hours and still present at discharge receive an implantable loop recorder device (Reveal ICM LINQae) placed under the skin to continuously record heart activity. Follow-up visits are scheduled at 1, 12, 24, and 36 months after the procedure, with additional visits if symptoms or significant arrhythmias develop. The device is checked manually during these visits, and phone follow-ups occur every three months. Participants will undergo regular outpatient assessments including device interrogation, symptom evaluation, and ECG monitoring. The study measures include the rate and timing of high-degree or complete AVB, arrhythmic events detected by the device leading to treatment changes or adverse events, and changes in heart function over up to three years. The total participation duration can be up to 36 months with ongoing safety and clinical monitoring.

Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study