About this trial
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.
Eligibility criteria
Qualifiers
De novo LBBB with QRS complex >150ms and/or PR interval ≥240ms.
QRS widening or post-procedural PR lengthening > 20ms in patients with baseline ECG-CDs.
Disqualifiers
Patients with previous pacemaker or implantable defibrillator.
Patients with baseline complete right bundle branch block.
Patients in need of cardiac resynchronization or physiological stimulation following TAVI.
Valve-in-valve procedures.
Trial design
Treatments tested in this trial
- Electrophysiological study (EP study)
- ePatch (extended Holter Monitoring)
Treatment groups
Sponsors and collaborators
Institut d'Investigació Biomèdica de Bellvitge
Lead sponsor
Hospital Universitari de Bellvitge
Collaborator
Hospital Universitario La Paz
Collaborator
Hospital Vall d'Hebron
Collaborator
Hospital Universitario Ramon y Cajal
Collaborator
Hospital Universitario A Coruna Spain
Collaborator
Hospital Clinico Universitario de Santiago
Collaborator
Hospital Universitario Central de Asturias
Collaborator
Hospital Universitario Marqués de Valdecilla
Collaborator
Hospital Clínico Universitario de Valladolid
Collaborator