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Harmony TPV Post-Approval Study

Primary Purpose

Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harmony TPV System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
  • Patient (or patient's legally authorized representative) is willing to consent to participate in the study

Exclusion Criteria:

  • Anatomy unable to accommodate a 25 Fr delivery catheter system
  • Obstruction of the central veins
  • Clinical or biological signs of infection including active endocarditis
  • Planned concomitant branch pulmonary artery stenting at time of implant
  • Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of childbearing potential
  • Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-PA conduit implant
  • A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
  • Planned implantation of the Harmony TPV in the left heart
  • Known allergy to aspirin, heparin, or nickel
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Pre-existing prosthetic heart valve or prosthetic ring in any position

Sites / Locations

  • University of Alabama at Birmingham HospitalRecruiting
  • Phoenix Children'sRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Children's Hospital ColoradoRecruiting
  • St. Joseph Children's HospitalRecruiting
  • Advocate Christ Medical CenterRecruiting
  • Boston Children's HospitalRecruiting
  • University of Michigan Health SystemRecruiting
  • Saint Louis Children's HospitalRecruiting
  • Children's Hospital & Medical CenterRecruiting
  • The Mount Sinai HospitalRecruiting
  • Children's Hospital New York - PresbyterianRecruiting
  • Atrium Health Levine Children's HospitalRecruiting
  • Duke University Medical CenterRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Cleveland ClinicRecruiting
  • UPMC Children's Hospital of Pittsburgh
  • Medical City Children's HospitalRecruiting
  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Harmony TPV System

Arm Description

Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System

Outcomes

Primary Outcome Measures

Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND Pulmonary regurgitant fraction as measured by CMR <20%

Secondary Outcome Measures

Percentage of subjects free from all-cause mortality at 6-months
Described by Kaplan-Meier statistics at 6-months.
Percentage of subjects free from reoperation at 6-months
Described by Kaplan-Meier statistics at 6-months.
Percentage of subjects free from catheter reintervention at 6-months
Described by Kaplan-Meier statistics at 6-months.
Percentage of subjects free from TPV dysfunction at 6-months
Described by Kaplan-Meier statistics at 6-months.
Number and percentage of subjects with procedure success at 30-days
Number and percentage of subjects with serious device-related adverse events at 6 months
Also described with Kaplan-Meier method for AEs of clinical interest.

Full Information

First Posted
September 30, 2021
Last Updated
September 26, 2023
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT05077774
Brief Title
Harmony TPV Post-Approval Study
Official Title
Harmony TPV Post-Approval Study (Harmony PAS2)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
March 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Harmony TPV System
Arm Type
Other
Arm Description
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System
Intervention Type
Device
Intervention Name(s)
Harmony TPV System
Other Intervention Name(s)
Model Numbers: HARMONY-22, HARMONY-25, and HARMONY-DCS
Intervention Description
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
Primary Outcome Measure Information:
Title
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
Description
Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND Pulmonary regurgitant fraction as measured by CMR <20%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of subjects free from all-cause mortality at 6-months
Description
Described by Kaplan-Meier statistics at 6-months.
Time Frame
6 months
Title
Percentage of subjects free from reoperation at 6-months
Description
Described by Kaplan-Meier statistics at 6-months.
Time Frame
6 months
Title
Percentage of subjects free from catheter reintervention at 6-months
Description
Described by Kaplan-Meier statistics at 6-months.
Time Frame
6 months
Title
Percentage of subjects free from TPV dysfunction at 6-months
Description
Described by Kaplan-Meier statistics at 6-months.
Time Frame
6 months
Title
Number and percentage of subjects with procedure success at 30-days
Time Frame
30-days
Title
Number and percentage of subjects with serious device-related adverse events at 6 months
Description
Also described with Kaplan-Meier method for AEs of clinical interest.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment Patient (or patient's legally authorized representative) is willing to consent to participate in the study Exclusion Criteria: Anatomy unable to accommodate a 25 Fr delivery catheter system Obstruction of the central veins Clinical or biological signs of infection including active endocarditis Planned concomitant branch pulmonary artery stenting at time of implant Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of childbearing potential Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-PA conduit implant A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year Planned implantation of the Harmony TPV in the left heart Known allergy to aspirin, heparin, or nickel Echocardiographic evidence of intracardiac mass, thrombus, or vegetation Pre-existing prosthetic heart valve or prosthetic ring in any position
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Vanney
Phone
763-514-4000
Email
RS.HarmonyPAS2@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Harmony Clinical Study Central Email
Email
RS.HarmonyPAS2@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Balzer, MD
Organizational Affiliation
St. Louis Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Law, MD
Facility Name
Phoenix Children's
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Graziano, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Zahn, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth Morgan, MD
Facility Name
St. Joseph Children's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Ringewald, MD
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhaval Patel, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Porras, MD
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Whiteside, MD
Facility Name
Saint Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Balzer, MD
Facility Name
Children's Hospital & Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Delaney, MD
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Love, MD
Facility Name
Children's Hospital New York - Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Crystal, MD
Facility Name
Atrium Health Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Paolillo, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Fleming, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shabana Shahanavaz, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Ghobrial, MD
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical City Children's Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Dimas, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Withdrawn

12. IPD Sharing Statement

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Harmony TPV Post-Approval Study

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