Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
NCT ID: NCT00688571
Last Updated: 2015-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2007-10-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Melody TPV Implant
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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John Hess, Prof.
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum München
Felix Berger, Prof.
Role: PRINCIPAL_INVESTIGATOR
German Heart Institute
Lars Soendergaard, Dr.
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Maria Giulia Gagliardi, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Bambino Gesu Rome
Jose Suarez de Lezo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Reina Sofia Cordoba
Lee Benson, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Maarten Witsenburg, Dr.
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Rigshospitalet Copenhagen
Copenhagen, , Denmark
Deutsches Herzzentrum Berlin
Berlin, , Germany
Deutsches Herzzentrum München
München, , Germany
Hospital Bambino Gesu Roma
Rome, , Italy
Erasmus Medical Center
Rotterdam, , Netherlands
Hospital Reina Sofia
Córdoba, , Spain
Countries
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References
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Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung TH, Eicken A, McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16.
McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4.
Other Identifiers
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BRC-CS-PMSS
Identifier Type: -
Identifier Source: org_study_id
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