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Recruiting NCT06481137

Reversibility of Cardiac Conduction Disturbances Following TAVI

No phase Interventional Aortic Stenosis Transcatheter Aortic Valve Implantation Conduction Disturbances

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrophysiological study (EP study), ePatch (extended Holter Monitoring).
Who it may be relevant to
Registry conditions: Aortic Stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Spain · 1 center
  • Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Identifiers

NCT: NCT06481137 · ICPS025/24 · PI23/00310

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗