Reversibility of Cardiac Conduction Disturbances Following TAVI

The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block. In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI. In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.

NCT Number	NCT06481137
Lead Sponsor	Institut d'Investigació Biomèdica de Bellvitge Collaborators: Hospital Universitari de Bellvitge, Hospital Universitario La Paz, Hospital Vall d'Hebron, Hospital Universitario Ramon y Cajal, Hospital Universitario A Coruna Spain, Hospital Clinico Universitario de Santiago, Hospital Universitario Central de Asturias, Hospital Universitario Marqués de Valdecilla, Hospital Clínico Universitario de Valladolid
Conditions	Aortic Stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances
Enrollment	209 participants
Start Date	2024-06-17
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-07-01