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Melody PB1016 Surveillance Study

Primary Purpose

Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Melody Transcatheter Pulmonary Valve PB1016
Sponsored by
Medtronic Heart Valves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University of California - Los Angeles
  • Children's Hospital of Michigan
  • Nationwide Childrens Hospital
  • Primary Children's Hospital
  • Seattle Childrens and Regional Hospital
  • Landes-Kinderklinik
  • Stollery Childrens Hospital
  • Hospital General Universitario Gregorio Marañón

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Melody TPV PB1016

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year
Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following: Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation.
Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years
Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following: Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation.
Number of Subjects With Serious Procedure-related and Device-related Adverse Events
Serious procedure-related adverse events at 1year and 2 years post-implant Serious device-related adverse events at 1 year and 2 years post-implant
Number of Subjects With Procedural Success
A successful implant is defined as follows: Melody TPV PB1016 is fixated within the desired location RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is < 35 mmHg No more than trace/trivial pulmonary regurgitation by angiography Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant.
Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016
Kaplan-Meier: Freedom from Stent Fracture Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016 Kaplan-Meier: Freedom from RVOT Conduit Operation Kaplan-Meier: Freedom from Death (All-Cause)

Full Information

First Posted
September 12, 2014
Last Updated
October 22, 2019
Sponsor
Medtronic Heart Valves
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1. Study Identification

Unique Protocol Identification Number
NCT02347189
Brief Title
Melody PB1016 Surveillance Study
Official Title
Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
August 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Heart Valves

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melody TPV PB1016
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Melody Transcatheter Pulmonary Valve PB1016
Primary Outcome Measure Information:
Title
Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months
Description
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
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year
Description
Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following: Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation.
Time Frame
1 Year
Title
Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years
Description
Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following: Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation.
Time Frame
2 Years
Title
Number of Subjects With Serious Procedure-related and Device-related Adverse Events
Description
Serious procedure-related adverse events at 1year and 2 years post-implant Serious device-related adverse events at 1 year and 2 years post-implant
Time Frame
1 Year, 2 Years
Title
Number of Subjects With Procedural Success
Description
A successful implant is defined as follows: Melody TPV PB1016 is fixated within the desired location RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is < 35 mmHg No more than trace/trivial pulmonary regurgitation by angiography Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant.
Time Frame
At Time Of Procedure
Title
Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016
Description
Kaplan-Meier: Freedom from Stent Fracture Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016 Kaplan-Meier: Freedom from RVOT Conduit Operation Kaplan-Meier: Freedom from Death (All-Cause)
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nationwide Childrens Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Seattle Childrens and Regional Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Landes-Kinderklinik
City
Linz
Country
Austria
Facility Name
Stollery Childrens Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30419603
Citation
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.
Results Reference
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Melody PB1016 Surveillance Study

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