Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
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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
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Condition or disease | Intervention/treatment | Phase |
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Heart Valve Diseases | Device: Melody Transcatheter Pulmonary Valve | Not Applicable |
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 |

Arm | Intervention/treatment |
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Experimental: Melody TPV Implant
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.
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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 |
- 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 ]
- Procedural success [ Time Frame: August 2014 ]
- Incidence of device and procedure related adverse events [ Time Frame: August 2014 ]
- Hemodynamic Performance [ Time Frame: August 2014 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
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 |
Pulmonary Valve Congenital Heart Disease |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |