Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study

October 28, 2015 updated by: Medtronic Bakken Research Center

Melody TPV Post-Market Surveillance Study

This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

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 Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet Copenhagen
  • Germany
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum Berlin
      • München, Germany, 80636
        • Deutsches Herzzentrum München
  • Italy
      • Rome, Italy, 00165
        • Hospital Bambino Gesu Roma
  • Netherlands
      • Rotterdam, Netherlands, 3015CE
        • Erasmus Medical Center
  • Spain
      • Cordoba, Spain, 14004
        • Hospital Reina Sofía

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

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Prospective subjects have complex congenital heart defects that have been palliated with RVOT conduits that have become dysfunctional and have a clinical indication for invasive intervention. Prospective subjects must meet all of following inclusion and exclusion criteria:

Inclusion Criteria:

  • Age greater than or equal to 5 years of age
  • Weight greater than or equal to 30 kilograms
  • Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
  • Any of the following by transthoracic echocardiography

For patients in NYHA Classification II, III, or IV:

  • Moderate (3+) or severe (4+) pulmonary regurgitation, or
  • Mean RVOT gradient greater than or equal to 35 mmHg.

For patients in NYHA Classification I:

  • Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction, or
  • Mean RVOT gradient greater than or equal to 40 mmHg.

Exclusion Criteria:

  • Active endocarditis
  • A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
  • Patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
  • Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
  • Known intravenous drug abuse

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melody TPV Implant
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.
Device: Melody Transcatheter Pulmonary Valve
Transcatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death
Time Frame: August 2014
August 2014

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success
Time Frame: August 2014
August 2014
Incidence of device and procedure related adverse events
Time Frame: August 2014
August 2014
Hemodynamic Performance
Time Frame: August 2014
August 2014

Collaborators and Investigators

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

Sponsor

Medtronic Bakken Research Center

Collaborators

Medtronic

Investigators

  • Principal Investigator: John Hess, Prof., Deutsches Herzzentrum München
  • Principal Investigator: Felix Berger, Prof., German Heart Institute
  • Principal Investigator: Lars Soendergaard, Dr., Rigshospitalet, Denmark
  • Principal Investigator: Maria Giulia Gagliardi, Dr., Ospedale Bambino Gesu Rome
  • Principal Investigator: Jose Suarez de Lezo, Dr., Hospital Reina Sofía Cordoba
  • Principal Investigator: Lee Benson, Dr., The Hospital for Sick Children
  • Principal Investigator: Maarten Witsenburg, Dr., Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRC-CS-PMSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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