Back to resultsMelody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
Primary Purpose
Heart Valve Diseases
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Melody Transcatheter Pulmonary Valve
Sponsored by
About this trial
This is an interventional treatment trial for Heart Valve Diseases focused on measuring Pulmonary Valve, Congenital Heart Disease
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
Sites / Locations
- The Hospital for Sick Children
- Rigshospitalet Copenhagen
- Deutsches Herzzentrum Berlin
- Deutsches Herzzentrum München
- Hospital Bambino Gesu Roma
- Erasmus Medical Center
- Hospital Reina Sofia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Melody TPV Implant
Arm Description
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.
Outcomes
Primary Outcome Measures
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death
Secondary Outcome Measures
Procedural success
Incidence of device and procedure related adverse events
Hemodynamic Performance
Full Information
NCT ID
NCT00688571
First Posted
May 30, 2008
Last Updated
October 28, 2015
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00688571
Brief Title
Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
Official Title
Melody TPV Post-Market Surveillance Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
Pulmonary Valve, Congenital Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melody TPV Implant
Arm Type
Experimental
Arm Description
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.
Intervention Type
Device
Intervention Name(s)
Melody Transcatheter Pulmonary Valve
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Procedural success
Time Frame
August 2014
Title
Incidence of device and procedure related adverse events
Time Frame
August 2014
Title
Hemodynamic Performance
Time Frame
August 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hess, Prof.
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix Berger, Prof.
Organizational Affiliation
German Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Soendergaard, Dr.
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Giulia Gagliardi, Dr.
Organizational Affiliation
Ospedale Bambino Gesu Rome
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Suarez de Lezo, Dr.
Organizational Affiliation
Hospital Reina Sofia Cordoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lee Benson, Dr.
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maarten Witsenburg, Dr.
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Rigshospitalet Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
München
ZIP/Postal Code
80636
Country
Germany
Facility Name
Hospital Bambino Gesu Roma
City
Rome
ZIP/Postal Code
00165
Country
Italy
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015CE
Country
Netherlands
Facility Name
Hospital Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
31419019
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.
Results Reference
derived
PubMed Identifier
23735475
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.
Results Reference
derived
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Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
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