Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

March 4, 2024 updated by: Medtronic Cardiovascular

Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (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 evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • New York
      • New York, New York, United States, 10032
        • Children's Hospital of NY-Presbyterian
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's and Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Melody Transcatheter Pulmonary Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From TPV Dysfunction at 10 Years
Time Frame: 10 years
The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg).
10 years
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
Within 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).
5 years
Serious Procedural Adverse Event (AE)
Time Frame: 10 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).
10 years
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).
5 years
Serious Device-related Adverse Event
Time Frame: 10 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).
10 years
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.
5 years
Kaplan-Meier Freedom From Major Stent Fracture at 10 Years
Time Frame: 10 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.
10 years
Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Time Frame: 5 years
Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
5 years
Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Time Frame: 10 years
Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
10 years
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Time Frame: 5 years
Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
5 years
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Time Frame: 10 years
Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
10 years
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Time Frame: 5 years
Deaths is defined as all-cause, procedural and device-related events at 5 years
5 years
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Time Frame: 10 years
Deaths is defined as all-cause, procedural and device-related events at 10 years
10 years
Functional Assessment (NYHA Classification)
Time Frame: 6 Months
Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 21, 2020

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimated)

August 25, 2008

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G050186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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