Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
This study has been completed.
Sponsor:
Medtronic Bakken Research Center
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT00688571
First received: May 30, 2008
Last updated: October 28, 2015
Last verified: October 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Valve Diseases |
Device: Melody Transcatheter Pulmonary Valve |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Melody TPV Post-Market Surveillance Study |
Resource links provided by NLM:
Further study details as provided by Medtronic Cardiovascular:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Procedural success [ Time Frame: August 2014 ] [ Designated as safety issue: No ]
- Incidence of device and procedure related adverse events [ Time Frame: August 2014 ] [ Designated as safety issue: No ]
- Hemodynamic Performance [ Time Frame: August 2014 ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Melody TPV Implant
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.
|
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
|
Eligibility| Ages Eligible for Study: | 5 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688571
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688571
Locations
| 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 | |
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
| 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, Rotterdam |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT00688571 History of Changes |
| Other Study ID Numbers: | BRC-CS-PMSS |
| Study First Received: | May 30, 2008 |
| Last Updated: | October 28, 2015 |
| Health Authority: | Germany: German Institute of Medical Documentation and Information |
Keywords provided by Medtronic Cardiovascular:
|
Pulmonary Valve Congenital Heart Disease |
Additional relevant MeSH terms:
|
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 29, 2016