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Infective Endocarditis in Percutaneous Pulmonary Revalvulation: Comparison Between Melody and Sapien Valves

NCT06186258 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-12-29

No results posted yet for this study

Summary

Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction. The Melody valve (Medtronic Inc., Minneapolis, Minnesota) was the first to be used, validated in 2006 by the European Commission and in 2010 by the Food and Drug Administration (FDA). Subsequently, the Sapien valve (Edwards SAPIEN pulmonic transcatheter heart valve, Edwards Lifesciences, Irvine, California) was subsequently approved for PPVR (Europe, 2010; FDA 2016).

Infective endocarditis (IE) after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3%, much higher than the rate of prosthetic left-heart IE. The Sapien valve has been introduced more recently and some cases of IE have been published. Despite the attention this issue is receiving, there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted. Recently, a multicenter study was published by the American team of McElhinney et al (J Am Coll Cardiol 2021 ; 78 :575-589). Although it was a sizeable cohort (2476 patients), there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve, in favor of Melody patients (2038 Melody patients vs. 438 Sapien patients). In this study, the estimated risk of IE was higher for patients who received a Melody valve, according to univariable analysis but not anymore after multivariate analysis. To further answer this question, we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted (Melody vs. Sapien) using a large population of patients with comparable characteristics (match-population).

Conditions

  • Infective Endocarditis
  • Congenital Heart Disease
  • Percutaneous Pulmonary Valve Implantation

Interventions

DEVICE

percutaneous pulmonary valve implantation (PPVI)

The only inclusion criterion is a successful PPVI to treat RVOT dysfunction. Procedural techniques were at each operator's discretion as well as post-procedure treatments and patient's follow-up. As we sought to assess IE incidence during follow-up, patients who underwent catheterization for intended PPVI but who did not had a successful valve implantation were not included. Successful PPVI was defined as patient discharged alive without valve surgery after successful valve implantation in the RVOT.

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

  • Alain Fraisse, MD, PhD · Royal Brompton & Harefield NHS Foundation Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • France
  • Germany
  • Italy
  • Portugal
  • Saudi Arabia
  • Spain
  • United Kingdom

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 NCT06186258 on ClinicalTrials.gov