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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

August 21, 2008
March 4, 2014
January 2007
February 2015   (final data collection date for primary outcome measure)
Long-Term Functionality of Melody [ Time Frame: Five years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00740870 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Original IDE Cohort
Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional RVOT Conduits: A Feasibility Study

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Complex Congenital Heart Defect
  • Dysfunctional RVOT Conduits
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
August 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
5 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00740870
G050186
Yes
Medtronic Heart Valves
Medtronic Heart Valves
Not Provided
Not Provided
Medtronic Heart Valves
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP