Reversibility of Cardiac Conduction Disturbances Following TAVI

Summary

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.

Conditions

• Aortic Stenosis
• Transcatheter Aortic Valve Implantation
• Conduction Disturbances

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

ePatch (extended Holter Monitoring)

Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI

Sponsors & Collaborators

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Universitario A Coruna Spain

  collaborator UNKNOWN

• Hospital Clinico Universitario de Santiago

  collaborator OTHER

• Hospital Universitario Central de Asturias

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• Institut d'Investigació Biomèdica de Bellvitge

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-17

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Spain

Study Locations