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Reversibility of Cardiac Conduction Disturbances Following TAVI

RecruitingNAAges 18 Years - anyAllInstitut d'Investigació Biomèdica de Bellvitge
NCT06481137 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, the

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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. * TAVI procedures in patients with severe aortic insufficiency. * Inability to sign the informed consent form.
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What it tests

  • Electrophysiological study (EP study)
  • ePatch (extended Holter Monitoring)
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Where

1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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