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Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

Primary Purpose

Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcatheter Pulmonary Valve replacement
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Nicklaus Children's Hospital
  • Children's Hospital Boston
  • Children's Hospital of NY-Presbyterian
  • Nationwide Children's Hospital
  • Seattle Children's and Regional Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melody TPV Implant

Arm Description

Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Freedom From TPV Dysfunction at 10 Years
The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg).
Procedural Success
Procedural success is a composite outcome defined as: Melody TPV fixated within the desired location Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant Less than mild pulmonary regurgitation by angiography post-implant Free of explant at 24 hours post-implant
Serious Procedural Adverse Event (AE)
A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Serious Procedural Adverse Event (AE)
A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Serious Device-related Adverse Event
A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Serious Device-related Adverse Event
A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Kaplan-Meier Freedom From Major Stent Fracture at 5 Years
Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Kaplan-Meier Freedom From Major Stent Fracture at 10 Years
Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Deaths is defined as all-cause, procedural and device-related events at 5 years
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Deaths is defined as all-cause, procedural and device-related events at 10 years
Functional Assessment (NYHA Classification)
Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.

Full Information

First Posted
August 21, 2008
Last Updated
March 18, 2021
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00740870
Brief Title
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
Official Title
Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 21, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Melody TPV Implant
Arm Type
Experimental
Arm Description
Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.
Intervention Type
Device
Intervention Name(s)
Transcatheter Pulmonary Valve replacement
Other Intervention Name(s)
Melody Transcatheter Pulmonary Valve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kaplan-Meier Freedom From TPV Dysfunction
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Freedom From TPV Dysfunction at 10 Years
Description
The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg).
Time Frame
10 years
Title
Procedural Success
Description
Procedural success is a composite outcome defined as: Melody TPV fixated within the desired location Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant Less than mild pulmonary regurgitation by angiography post-implant Free of explant at 24 hours post-implant
Time Frame
Within 24 Hours post implant
Title
Serious Procedural Adverse Event (AE)
Description
A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Time Frame
5 years
Title
Serious Procedural Adverse Event (AE)
Description
A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Time Frame
10 years
Title
Serious Device-related Adverse Event
Description
A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Time Frame
5 years
Title
Serious Device-related Adverse Event
Description
A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Time Frame
10 years
Title
Kaplan-Meier Freedom From Major Stent Fracture at 5 Years
Description
Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Time Frame
5 years
Title
Kaplan-Meier Freedom From Major Stent Fracture at 10 Years
Description
Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Time Frame
10 years
Title
Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Description
Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
Time Frame
5 years
Title
Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Description
Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
Time Frame
10 years
Title
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Description
Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
Time Frame
5 years
Title
Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Description
Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
Time Frame
10 years
Title
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Description
Deaths is defined as all-cause, procedural and device-related events at 5 years
Time Frame
5 years
Title
Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Description
Deaths is defined as all-cause, procedural and device-related events at 10 years
Time Frame
10 years
Title
Functional Assessment (NYHA Classification)
Description
Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of NY-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Seattle Children's and Regional Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34930015
Citation
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.
Results Reference
derived
PubMed Identifier
31419019
Citation
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.
Results Reference
derived
PubMed Identifier
30682562
Citation
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. Erratum In: Am Heart J. 2019 Jul;213:126.
Results Reference
derived
PubMed Identifier
27453127
Citation
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.
Results Reference
derived
PubMed Identifier
25944758
Citation
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.
Results Reference
derived
PubMed Identifier
23735475
Citation
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.
Results Reference
derived
PubMed Identifier
22075927
Citation
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.
Results Reference
derived
PubMed Identifier
20644013
Citation
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.
Results Reference
derived

Learn more about this trial

Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

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