Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Original IDE Cohort (Melody IDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Heart Valves
ClinicalTrials.gov Identifier:
NCT00740870
First received: August 21, 2008
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.


Condition Intervention
Complex Congenital Heart Defect
Dysfunctional RVOT Conduits
Device: Transcatheter Pulmonary Valve replacement (Melody Transcatheter Pulmonary Valve)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional RVOT Conduits: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Medtronic Heart Valves:

Primary Outcome Measures:
  • Long-Term Functionality of Melody [ Time Frame: Five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of Subjects with Procedural Success [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Procedural Adverse Events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Serious Device-related Adverse Events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Stent fracture [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Catheter Re-intervention on TPV [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Surgical Replacement of the RVOT Conduit [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Death (all-cause, procedural and device-related) [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Functional Assessment (NYHA Classification) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: January 2007
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter Pulmonary Valve replacement (Melody Transcatheter Pulmonary Valve)
    Replacement of conduits in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.
    Other Name: Melody Transcatheter Pulmonary Valve
  Eligibility

Ages Eligible for Study:   5 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 16mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18mm and less than or equal to 22mm when originally implanted.
  • Any of the following by transthoracic echocardiography:
  • Patient in NYHA Classification II, III, or IV:
  • Moderate (3+) or severe (4+) pulmonary regurgitation
  • Mean RVOT gradient greater than or equal to 35mmHg
  • Patients in NYHA Classification I:
  • Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction
  • Mean RVOT gradient greater or equal to 40mmHg

Exclusion Criteria:

  • Active endocarditis
  • Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year
  • Patient or 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
  • Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential
  • 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: NCT00740870

Locations
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, New York
Children's Hospital of NY-Presbyterian
New York, New York, United States, 10032-3784
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Washington
Seattle Children's and Regional Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Medtronic Heart Valves
  More Information

Publications:
Odendaal D, Khambadkone S, Coats L, Taylor A, Mist B, Deanfield J, Bonhoeffer P, Derrick G. Maintained improvement in maximal exercise and continued improvement in sub-maximal exercise indices are seen during follow-up after percutaneous pulmonary valve insertion. Circulation. 114(8, Suppl. S): 558, Oct 2006.
Nordmeyer J, Coats L, Taylor AM, Khambackone S, Derrick G, Lee TY, Walker F, Bonhoeffer P. Benefits of percutaneous pulmonary valve implantation are sustained after 1 year Circulation. 114 (18, Suppl. S): 390;Oct 2006
Almeida CL, Chaturvedi R, Lee KJ, Horlick E, Smith G, Li J, Slorach C, Shimizu M, Golding F, Yoo SJ, Bonhoeffer P, Benson LN. Percutaneous pulmonary valve implantation - The first north American trial. Circulation. 114 (18, Suppl. S):389; Oct 2006
Frigiola A, Tsang V, Nordmeyer J, Lurz P, van Doom D, Taylor A.M., Bonhoeffer, P, de Leval, M.Current approaches to pulmonary regurgitation European Journal of Cardio-thoracic Surgery. 2008
Coats L, Khambadkone S, Derrick G, Hughes M, Mist B, Jones R, Marek J, Deanfield JE, Bonhoeffer P, Taylor AM. Relief of chronic pulmonary regurgitation with percutaneous valve implantation acutely improves ventricular performance but not exercise capacity. Circulation. 114 (18, Suppl. S):390;Oct 2006

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Heart Valves
ClinicalTrials.gov Identifier: NCT00740870     History of Changes
Other Study ID Numbers: G050186
Study First Received: August 21, 2008
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Heart Valves:
RVOT
Dysfunctional
conduit
Indications
Invasive
intervention
Tetralogy of Fallot

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 30, 2014