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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688571
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : October 29, 2015
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Heart Valve Diseases Device: Melody Transcatheter Pulmonary Valve Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Melody TPV Post-Market Surveillance Study
Study Start Date : October 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Procedural success [ Time Frame: August 2014 ]
  2. Incidence of device and procedure related adverse events [ Time Frame: August 2014 ]
  3. Hemodynamic Performance [ Time Frame: August 2014 ]

Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688571


Locations
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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
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00688571    
Other Study ID Numbers: BRC-CS-PMSS
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
Pulmonary Valve
Congenital Heart Disease
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases