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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00688571
First received: May 30, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Heart Valve Diseases
Device: Melody Transcatheter Pulmonary Valve

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Melody TPV Post-Market Surveillance Study

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedural success [ Time Frame: August 2014 ] [ Designated as safety issue: No ]
  • Incidence of device and procedure related adverse events [ Time Frame: August 2014 ] [ Designated as safety issue: No ]
  • Hemodynamic Performance [ Time Frame: August 2014 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
The target population includes male and female patients with dysfunctional RVOT conduits.
Device: Melody Transcatheter Pulmonary Valve
Transcatheter Pulmonary Valve Replacement
Other Name: Melody Transcatheter Pulmonary Valve

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688571

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark, 2100
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Deutsches Herzzentrum München
München, Germany, 80636
Italy
Hospital Bambino Gesu Roma
Rome, Italy, 00165
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3015CE
Spain
Hospital Reina Sofia
Cordoba, Spain, 14004
Sponsors and Collaborators
Medtronic Bakken Research Center
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 Sofia Cordoba
Principal Investigator: Lee Benson, Dr. The Hospital for Sick Children
Principal Investigator: Maarten Witsenburg, Dr. Erasmus Medical Center Rotterdam
  More Information

No publications provided by Medtronic Bakken Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00688571     History of Changes
Other Study ID Numbers: BRC-CS-
Study First Received: May 30, 2008
Last Updated: August 8, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Medtronic Bakken Research Center:
Pulmonary Valve
Congenital Heart Disease

Additional relevant MeSH terms:
Heart Valve Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014