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

Not Applicable

Completed

• Conditions: Heart Valve Diseases
• Interventions: Device: Melody Transcatheter Pulmonary Valve

• Registration Number: NCT00688571
• Lead Sponsor: Medtronic Bakken Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melody TPV Implant	Melody Transcatheter Pulmonary Valve	Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.

Primary Outcome Measures

Name	Time	Method
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death	August 2014

Secondary Outcome Measures

Name	Time	Method
Procedural success	August 2014
Hemodynamic Performance	August 2014
Incidence of device and procedure related adverse events	August 2014

Trial Locations

Locations (7)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Hospital Bambino Gesu Roma; 🇮🇹 Rome, Italy

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Rigshospitalet Copenhagen; 🇩🇰 Copenhagen, Denmark

Hospital Reina Sofia; 🇪🇸 Cordoba, Spain