Status:
COMPLETED
Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
5+ years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00688571
Start Date
October 1 2007
End Date
December 1 2014
Last Update
October 29 2015
Active Locations (7)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
2
Rigshospitalet Copenhagen
Copenhagen, Denmark, 2100
3
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
4
Deutsches Herzzentrum München
München, Germany, 80636