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Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot

NCT04205461 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-03-09

No results posted yet for this study

Summary

Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing.

Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch.

While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis.

At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking.

The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.

Conditions

  • Congenital Heart Disease
  • Fallot Tetralogy
  • Ventricular Arrythmia
  • Pulmonary Valve Regurgitation

Interventions

PROCEDURE

Programmed ventricular stimulation

Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.

Sponsors & Collaborators

  • European Georges Pompidou Hospital

    collaborator OTHER

  • Centre Chirurgical Marie Lannelongue

    collaborator OTHER

  • Clinique Pasteur Toulouse

    collaborator OTHER

  • Hopital Louis Pradel

    collaborator OTHER

  • Hôpital Necker-Enfants Malades

    collaborator OTHER

  • Paris Cardiovascular Research Center (Inserm U970)

    lead OTHER_GOV

Principal Investigators

  • Victor Waldmann, MD, MPH · European Georges Pompidou Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205461 on ClinicalTrials.gov