Congenital Heart DefectsNCT00740870
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
A study testing Transcatheter Pulmonary Valve replacement in people with Congenital Heart Defects and Dysfunctional Right Ventricular Outflow Tract Conduits, run by Medtronic Cardiovascular at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits
- What is being tested?
- Transcatheter Pulmonary Valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2007to 21 Aug 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Nationwide Children's Hospital
Columbus, Ohio, 43205
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Hospital of NY-Presbyterian
New York, New York, 10032
Seattle Children's and Regional Hospital
Seattle, Washington, 98105
About this study
Official title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study
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.
Read the 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.
- Being tested
- Transcatheter Pulmonary Valve replacement
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Pulmonary Valve replacementDevice
Also called Melody Transcatheter Pulmonary Valve
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.
| Study group | Role | What they receive |
|---|---|---|
| Melody TPV Implant | Experimental | Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit. Receives: Device: Transcatheter Pulmonary Valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (15)
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).
Measured: 10 years
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
Measured: Within 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).
Measured: 5 years
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).
Measured: 10 years
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).
Measured: 5 years
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).
Measured: 10 years
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.
Measured: 5 years
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.
Measured: 10 years
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
Measured: 5 years
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
Measured: 10 years
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
Measured: 5 years
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
Measured: 10 years
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
Measured: 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
Measured: 10 years
Functional Assessment (NYHA Classification)
Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionMay 2015
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740870
- Sponsor's protocol ID
- G050186
- Status last verified
- Mar 2024
- First submitted
- 21 Aug 2008
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34930015Armstrong 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.
PubMed 31419019Priromprintr 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.
PubMed 30682562Priromprintr 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.
PubMed 27453127Cheatham 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.
PubMed 25944758McElhinney 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.
PubMed 23735475McElhinney 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.
PubMed 22075927McElhinney 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.
PubMed 20644013