NCT02347189

Brief Summary

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
4 countries

8 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

First Submitted

Initial submission to the registry

September 12, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 29, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

November 6, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

September 12, 2014

Results QC Date

September 20, 2017

Last Update Submit

October 22, 2019

Conditions

Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months

    Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following: * Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and * Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation

    6 Months

Secondary Outcomes (5)

  • Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year

    1 Year

  • Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years

    2 Years

  • Number of Subjects With Serious Procedure-related and Device-related Adverse Events

    1 Year, 2 Years

  • Number of Subjects With Procedural Success

    At Time Of Procedure

  • Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016

    2 years

Study Arms (1)

Melody TPV PB1016

OTHER
Device: Melody Transcatheter Pulmonary Valve PB1016

Interventions

Melody Transcatheter Pulmonary Valve PB1016DEVICE
Melody TPV PB1016

Eligibility Criteria

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

You may qualify if:

  • Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment
  • Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

You may not qualify if:

  • Implantation in the aortic, tricuspid, 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
  • History of intravenous substance abuse
  • Currently participating in an investigational drug or device study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California - Los Angeles

Los Angeles, California, 90095, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Nationwide Childrens Hospital

Columbus, Ohio, 43205, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84132, United States

Location

Seattle Childrens and Regional Hospital

Seattle, Washington, 98105, United States

Location

Landes-Kinderklinik

Linz, Austria

Location

Stollery Childrens Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Related Publications (1)

  • Morray BH, Jones TK, Coe JY, Gitter R, Martinez JZ, Turner DR, Gray RG, Lung TH, Berman DP, Levi DS. Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):474-480. doi: 10.1002/ccd.27974. Epub 2018 Nov 12.

    PMID: 30419603DERIVED

Results Point of Contact

Title
Megan Mueller, Clinical Research Manager
Organization
Medtronic
megan.d.mueller@medtronic.com
612-916-4771

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
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

September 12, 2014

First Posted

January 27, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

August 10, 2018

Last Updated

November 6, 2019

Results First Posted

November 29, 2017

Record last verified: 2019-10

Locations

US(5)CA(1)ES(1)AU(1)