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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Electrophysiological study (EP study)
Diagnostic testElectrophysiological study: A second EP study 30-45 days after TAVI will be performed in the group of patients with positive EP study 3-7 days after TAVI.
ePatch (extended Holter Monitoring)
Diagnostic testContinuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI
Treatment groups
Trial outcomes
Primary outcomes
Incidence of retrogradation
1\. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.
Need for cardiac pacing (incidence of advanced atrioventricular block)
2\. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).
Sponsors and contacts
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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