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NCT Number: NCT06481137

Reversibility of Cardiac Conduction Disturbances Following TAVI

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Conduction Disturbances Heart Diseases Heart Valve Diseases Transcatheter Aortic Valve Implantation Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08097, Spain

Location status: Recruiting

Location contact

Andrea di Marco, MD, PhD

SUB_INVESTIGATOR

Guillem Muntané Carol, MD, PhD

PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

CONTACT

[email protected]

+342607500 ext. 7539

Julián Rodríguez García, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrophysiological study (EP study)

Diagnostic Test

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.

ePatch (extended Holter Monitoring)

Diagnostic Test

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

Primary outcomes

  1. Incidence of retrogradation

    Time frame: 30 days

    • Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.

  2. Need for cardiac pacing (incidence of advanced atrioventricular block)

    Time frame: 30 days

    • Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).

Study contacts

Contact information is provided by the study sponsor or research team.

Guillem Muntané Carol, MD, PhD

CONTACT

[email protected]

+342607500 ext. 7539

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Bellvitge

Other

Collaborators

  • Hospital Clinico Universitario de Santiago
  • Hospital Clínico Universitario de Valladolid
  • Hospital Universitari de Bellvitge
  • Hospital Universitario A Coruna Spain
  • Hospital Universitario Central de Asturias
  • Hospital Universitario La Paz
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Ramon y Cajal
  • Hospital Vall d'Hebron

Registry information

Official study title

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

Acronym: TAVI-REVERSE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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