Clinical trial NCT00688571: Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
Official title: Melody TPV Post-Market Surveillance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Pulmonary Valve
Congenital Heart Disease
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-06-03
Enrollment: 63
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death
timeFrame: August 2014
Secondary outcomes:
measure: Procedural success
timeFrame: August 2014
measure: Incidence of device and procedure related adverse events
timeFrame: August 2014
measure: Hemodynamic Performance
timeFrame: August 2014
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Rome
country: Italy
facility: Hospital Bambino Gesu Roma
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
Study officials:
affiliation: Deutsches Herzzentrum München
name: John Hess, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Heart Institute
name: Felix Berger, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Lars Soendergaard, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Bambino Gesu Rome
name: Maria Giulia Gagliardi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Reina Sofia Cordoba
name: Jose Suarez de Lezo, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Lee Benson, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Maarten Witsenburg, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.