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Melody Transcatheter Pulmonary Valve (TPV) Study: Post Approval Study of the Original Investigational Device Exemption (IDE) Cohort

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT00740870
First received: August 21, 2008
Last updated: May 31, 2017
Last verified: May 2017
  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
Congenital Heart Defects Dysfunctional Right Ventricular Outflow Tract Conduits Device: Transcatheter Pulmonary Valve replacement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Kaplan-Meier Freedom From TPV Dysfunction [ Time Frame: 5 years ]

    To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following:

    • Hemodynamic dysfunction of the TPV

      • Moderate or greater pulmonary regurgitation, and/or
      • Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg
    • RVOT reoperation for conduit dysfunction or device-related reasons
    • Catheter re-intervention on the TPV


Secondary Outcome Measures:
  • Procedural Success [ Time Frame: Within 24 Hours post implant ]

    Procedural success is a composite outcome defined as:

    • Melody TPV fixated within the desired location
    • Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant
    • Less than mild pulmonary regurgitation by angiography post-implant
    • Free of explant at 24 hours post-implant

  • Serious Procedural Adverse Event (AE) [ Time Frame: 5 years ]
    A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).

  • Serious Device-related Adverse Event [ Time Frame: 5 years ]
    A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).

  • Kaplan-Meier Freedom From Major Stent Fracture at 5 Years [ Time Frame: 5 years ]
    Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

  • Kaplan-Meier Freedom From Catheter Re-intervention on TPV [ Time Frame: 5 years ]
    All Catheter Re-intervention on TPV at 5 years

  • Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit [ Time Frame: 5 years ]
    Freedom From Surgical Replacement of the RVOT Conduit

  • Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) [ Time Frame: 5 years ]
    Deaths (all-cause, procedural and device-related) at 5 years

  • Functional Assessment (NYHA Classification) [ Time Frame: 6 Months ]
    Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.


Enrollment: 171
Study Start Date: January 2007
Estimated Study Completion Date: July 2020
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melody TPV Implant
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.
Device: Transcatheter Pulmonary Valve replacement
Transcatheter valve implantation into a RVOT conduit 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 and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 16 mm 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 18 mm and less than or equal to 22 mm when originally implanted.
  • Any of the following by transthoracic echocardiography:
  • For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/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 AND/OR Mean RVOT gradient greater or equal to 40 mmHg

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
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 Cardiovascular
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT00740870     History of Changes
Other Study ID Numbers: G050186
Study First Received: August 21, 2008
Results First Received: April 7, 2017
Last Updated: May 31, 2017

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

ClinicalTrials.gov processed this record on September 20, 2017