Dysfunctional Right Ventricular Outflow Tract (RVOT) ConduitNCT01186692
Melody® Transcatheter Pulmonary Valve Post-Approval Study
A study testing Melody® Transcatheter Pulmonary Valve in people with Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit, run by Medtronic Cardiovascular at 10 sites in United States.
Trial summary
The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
- What is being tested?
- Melody® Transcatheter Pulmonary Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2010to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
- Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)
Who cannot join
- Implantation in the aortic 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
- Unwilling or unable to provide written informed consent or comply with the follow-up requirements
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
CS Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, 48109
Children's Medical Center Dallas, UT Southwestern
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15201
Mayo Clinic
Rochester, Minnesota, 55905
Primary Children's Medical Center, University of Utah
Salt Lake City, Utah, 84113
Rady Children's Hospital
San Diego, California, 92123
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study
The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
- Being tested
- Melody® Transcatheter Pulmonary Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melody® Transcatheter Pulmonary ValveDevice
Also called Melody Transcatheter Pulmonary Valve
Transcatheter Pulmonary Valve replacement 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: Melody® Transcatheter Pulmonary Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation
Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:
- Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and
- Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and
- Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.
The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.
Measured: 6 months
Secondary outcomes (4)
Procedural Success
Procedural success is defined as a composite of the following:
- The TPV is fixated within the desired location, and
- The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and
- There is no more than trivial pulmonary regurgitation by angiography
- The subject is free from explantation of the TPV at 24 hours post-implant
Measured: 6 Months
Serious Procedural Adverse Events
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: 6 Months
Serious Device-related Adverse Events
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: 6 months
Changes in NYHA Functional Classification
Change in NYHA functional class from pre-implant to 6 month 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 posted23 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionOct 2017
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 (3)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional Right Ventricular Outflow Tract (RVOT) ConduitStudies 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaqueline Kreutzer, MD, Principal investigator, Children's Hospital of University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186692
- Sponsor's protocol ID
- D03909
- Status last verified
- Apr 2019
- First submitted
- 20 Aug 2010
- Last updated
- 1 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31419019Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62. doi: 10.1016/j.jcin.2014.08.002. Epub 2014 Nov 17.
PubMed 25459038McElhinney 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 23735475
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study
- ClinicalTrials.gov ID
- NCT01186692
- Acronym / sponsor ID
- D03909
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Jul 2010 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Posted 26 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melody TPV Implant | Experimental | Device: Melody® Transcatheter Pulmonary ValveMelody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
- Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)
Key exclusion criteria (5 listed)
- Implantation in the aortic 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
- Unwilling or unable to provide written informed consent or comply with the follow-up requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melody® Transcatheter Pulmonary ValveAlso: Melody Transcatheter Pulmonary ValveTranscatheter Pulmonary Valve replacement 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. | Device | Melody TPV Implant |
Primary outcome
Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation
Time frame: 6 months
Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.
4 secondary outcomes
Procedural Success
Time frame: 6 Months
Serious Procedural Adverse Events
Time frame: 6 Months
Serious Device-related Adverse Events
Time frame: 6 months
Changes in NYHA Functional Classification
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31419019Armstrong 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.
- Derived from this study: PubMed 25459038Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62. doi: 10.1016/j.jcin.2014.08.002. Epub 2014 Nov 17.
- Derived from this study: PubMed 23735475McElhinney 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaqueline Kreutzer, MD principal investigator
Children's Hospital of University of Pittsburgh Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melody® Transcatheter Pulmonary Valve in people with Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit, run by Medtronic Cardiovascular at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.