Reversibility of Cardiac Conduction Disturbances Following TAVI
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- Who runs it
- Institut d'Investigació Biomèdica de Bellvitge
- Trial code
- NCT06481137
- Record updated
- 1 July 2024
- Original description
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.Read full original descriptionShow less
InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study
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.
Inclusion: Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):; 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.
Exclusion: Patients with previous pacemaker or implantable defibrillator; Patients in need of cardiac resynchronization or physiological stimulation following TAVI; TAVI procedures in patients with severe aortic insufficiency; Patients with baseline complete right bundle branch block; Valve-in-valve procedures; Inability to sign the informed consent form.