NCT00740870

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2020

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

8.3 years

First QC Date

August 21, 2008

Results QC Date

April 7, 2017

Last Update Submit

March 4, 2024

Conditions

Congenital Heart DefectsDysfunctional Right Ventricular Outflow Tract Conduits

Outcome Measures

Primary Outcomes (1)

  • Kaplan-Meier Freedom From TPV Dysfunction

    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 Outcomes (15)

  • Freedom From TPV Dysfunction at 10 Years

    10 years

  • Procedural Success

    Within 24 Hours post implant

  • Serious Procedural Adverse Event (AE)

    5 years

  • Serious Procedural Adverse Event (AE)

    10 years

  • Serious Device-related Adverse Event

    5 years

  • +10 more secondary outcomes

Study Arms (1)

Melody TPV Implant

EXPERIMENTAL

Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

Device: Transcatheter Pulmonary Valve replacement

Interventions

Transcatheter Pulmonary Valve replacementDEVICE

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.

Also known as: Melody Transcatheter Pulmonary Valve
Melody TPV Implant

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may 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, 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of NY-Presbyterian

New York, New York, 10032, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Seattle Children's and Regional Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (8)

  • Jones TK, McElhinney DB, Vincent JA, Hellenbrand WE, Cheatham JP, Berman DP, Zahn EM, Khan DM, Rhodes JF Jr, Weng S, Bergersen LJ. Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial. Circ Cardiovasc Interv. 2022 Jan;15(1):e010852. doi: 10.1161/CIRCINTERVENTIONS.121.010852. Epub 2021 Dec 21.

    PMID: 34930015DERIVED

  • 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: 31419019DERIVED

  • Priromprintr B, Silka MJ, Rhodes J, Batra AS. A prospective 5-year study of exercise performance following Melody valve implant. Am Heart J. 2019 Mar;209:47-53. doi: 10.1016/j.ahj.2018.12.014. Epub 2018 Dec 29.

    PMID: 30682562DERIVED

  • Priromprintr B, Silka MJ, Rhodes J, Batra AS. A prospective 5-year study of the frequency of arrhythmias during serial exercise testing and clinical follow-up after Melody valve implant. Heart Rhythm. 2016 Nov;13(11):2135-2141. doi: 10.1016/j.hrthm.2016.07.023. Epub 2016 Jul 21.

    PMID: 27453127DERIVED

  • Cheatham JP, Hellenbrand WE, Zahn EM, Jones TK, Berman DP, Vincent JA, McElhinney DB. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. 2015 Jun 2;131(22):1960-70. doi: 10.1161/CIRCULATIONAHA.114.013588. Epub 2015 May 5.

    PMID: 25944758DERIVED

  • 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: 23735475DERIVED

  • McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. doi: 10.1161/CIRCINTERVENTIONS.111.965616. Epub 2011 Nov 9.

    PMID: 22075927DERIVED

  • McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3;122(5):507-16. doi: 10.1161/CIRCULATIONAHA.109.921692. Epub 2010 Jul 19.

    PMID: 20644013DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Karla Mezera
Organization
Medtronic
karla.p.mezera@medtronic.com
612-306-4325

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

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

August 21, 2008

First Posted

August 25, 2008

Study Start

January 1, 2007

Primary Completion

May 1, 2015

Study Completion

August 21, 2020

Last Updated

March 26, 2024

Results First Posted

July 2, 2017

Record last verified: 2024-03

Locations

US(5)