Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study

Heart Valve Diseases Clinical Trial

Official title:

Melody TPV Post-Market Surveillance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688571
• Other study ID #: BRC-CS-PMSS
• Status: Completed
• Phase: N/A
• First received: May 30, 2008
• Last updated: October 28, 2015
• Start date: October 2007
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Denmark	Rigshospitalet Copenhagen	Copenhagen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Deutsches Herzzentrum München	München
Italy	Hospital Bambino Gesu Roma	Rome
Netherlands	Erasmus Medical Center	Rotterdam
Spain	Hospital Reina Sofia	Cordoba

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Countries where clinical trial is conducted

Canada,  Denmark,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death		August 2014	No
Secondary	Procedural success		August 2014	No
Secondary	Incidence of device and procedure related adverse events		August 2014	No
Secondary	Hemodynamic Performance		August 2014	No