Melody® Transcatheter Pulmonary Valve Post-Approval Study

NCT01186692 | Completed Results

• 1 other identifier: D03909
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.

Conditions

Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit

Outcome Measures

Primary Outcomes (1)

• Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation

  Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.

  6 months

Secondary Outcomes (4)

• Procedural Success

  6 Months

• Serious Procedural Adverse Events

  6 Months

• Serious Device-related Adverse Events

  6 months

• Changes in NYHA Functional Classification

  6 Months

Study Arms (1)

Melody TPV Implant

EXPERIMENTAL

Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

Device: Melody® Transcatheter Pulmonary Valve

Interventions

Melody® Transcatheter Pulmonary Valve 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.

Also known as: Melody Transcatheter Pulmonary Valve

Melody TPV Implant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
• Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)

You may not qualify if:

• Implantation in the aortic or mitral position
• Venous anatomy unable to accommodate a 22-fr size introducer sheath
• Obstruction of the central veins
• Clinical or biological signs of infection including active endocarditis
• Unwilling or unable to provide written informed consent or comply with the follow-up requirements

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (10)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Advocate Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

CS Mott Children's Hospital, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15201, United States

Location

Children's Medical Center Dallas, UT Southwestern

Dallas, Texas, 75235, United States

Location

Primary Children's Medical Center, University of Utah

Salt Lake City, Utah, 84113, United States

Location

Related Publications (3)

• 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: 31419019 DERIVED

• Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62. doi: 10.1016/j.jcin.2014.08.002. Epub 2014 Nov 17.

  PMID: 25459038 DERIVED

• 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: 23735475 DERIVED

Results Point of Contact

• Title: Susan Patterson
• Organization: Medtronic

susan.patterson@medtronic.com

763.526.1544

Study Officials

• Jaqueline Kreutzer, MD

  Children's Hospital of University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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 20, 2010
• First Posted: August 23, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: October 1, 2017
• Last Updated: May 1, 2019
• Results First Posted: December 26, 2016

Record last verified: 2019-04

Locations

US (10)