Condition: Aortic Stenosis · Transcatheter Aortic Valve Implantation · Conduction Disturbances · Sponsor: Institut d'Investigació Biomèdica de Bellvitge
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.
This description comes directly from the study's public registry record.
Guillem Muntané Carol, MD, PhD · +342607500 · gmuntanec@bellvitgehospital.cat
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| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat, Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06481137