Reversibility of Cardiac Conduction Disturbances Following TAVI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Bellvitge

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

Qualifiers

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

Treatments tested in this trial

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

Treatment groups

209 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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