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

NCT00688571 | Completed

• 1 other identifier: BRC-CS-PMSS
• Study Type: interventional
• Target: 63
• Locations: 6 countries
• Sites: 7

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.

Conditions

Heart Valve Diseases

Keywords

Pulmonary Valve; Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

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

  August 2014

Secondary Outcomes (3)

• Procedural success

  August 2014

• Incidence of device and procedure related adverse events

  August 2014

• Hemodynamic Performance

  August 2014

Study Arms (1)

Melody TPV Implant

EXPERIMENTAL

Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit.

Device: Melody Transcatheter Pulmonary Valve

Interventions

Melody Transcatheter Pulmonary Valve DEVICE

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

Melody TPV Implant

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (7)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

Hospital Bambino Gesu Roma

Rome, 00165, Italy

Location

Erasmus Medical Center

Rotterdam, 3015CE, Netherlands

Location

Hospital Reina Sofia

Córdoba, 14004, Spain

Location

Related Publications (2)

• 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.

  PMID: 31419019 DERIVED

• 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.

  PMID: 23735475 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

DE (2); CA (1); DK (1); IT (1); ES (1); NL (1)