Reversibility of Cardiac Conduction Disturbances Following TAVI (TAVI-REVERSE)

June 25, 2024 updated by: Guillem Muntané Carol, Institut d'Investigació Biomèdica de Bellvitge

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • L' Hospitalet De Llobregat, Barcelona, Spain, 08097
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
        • Principal Investigator:
          • Guillem Muntané Carol, MD, PhD
        • Sub-Investigator:
          • Andrea di Marco, MD, PhD
        • Sub-Investigator:
          • Julián Rodríguez García, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive initial (3-7 days following TAVI) electrophysiological study (EP+)
Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI.
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
Other: Negative initial (3-7 days following TAVI) electrophysiological study (EP-)
Continuous ECG monitoring during 4 weeks.
Diagnostic test: ePatch (extended Holter Monitoring)
Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of retrogradation
Time Frame: 30 days
1. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.
30 days
Need for cardiac pacing (incidence of advanced atrioventricular block)
Time Frame: 30 days
2. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut d'Investigació Biomèdica de Bellvitge

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Estimated)

July 1, 2024

Study Record Updates

Last Update Posted (Estimated)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICPS025/24
  • PI23/00310 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study procotol and ICF will be shared trough PI request during the duration of the study

IPD Sharing Time Frame

During the duration of the study

IPD Sharing Access Criteria

Request to the PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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