Reversibility of Cardiac Conduction Disturbances Following TAVI

Официальное название

InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study

Обзор

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.

Вмешательства

• Диагностический тест Electrophysiological study (EP study)
  Electrophysiological 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.
• Диагностический тест ePatch (extended Holter Monitoring)
  Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI

Первичные конечные точки

• Incidence of retrogradation [Срок оценки: 30 days]
• Need for cardiac pacing (incidence of advanced atrioventricular block) [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Испания · 1 центр

• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Идентификаторы

NCT: NCT06481137 · ICPS025/24 · PI23/00310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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