Dysfunctional RVOT Conduits in Patients With Congenital Heart DefectsNCT02347189
Melody PB1016 Surveillance Study
A study testing Melody Transcatheter Pulmonary Valve PB1016 in people with Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects, run by Medtronic Heart Valves at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
- What is being tested?
- Melody Transcatheter Pulmonary Valve PB1016
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2014to 10 Aug 2018
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States5 sites
Nationwide Childrens Hospital
Columbus, Ohio, 43205
Children's Hospital of Michigan
Detroit, Michigan, 48201
University of California - Los Angeles
Los Angeles, California, 90095
Primary Children's Hospital
Salt Lake City, Utah, 84132
Seattle Childrens and Regional Hospital
Seattle, Washington, 98105
About this 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
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.
- Being tested
- Melody Transcatheter Pulmonary Valve PB1016
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melody Transcatheter Pulmonary Valve PB1016Device
| Study group | Role | What they receive |
|---|---|---|
| Melody TPV PB1016 | Other | Not described Receives: Device: Melody Transcatheter Pulmonary Valve PB1016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Months
Secondary outcomes (5)
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.
Measured: 1 Year
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.
Measured: 2 Years
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
Measured: 1 Year, 2 Years
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.
Measured: At Time Of Procedure
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completion10 Aug 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional RVOT Conduits in Patients With Congenital Heart DefectsStudies of the same condition, open and under way.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Heart Valves
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347189
- Sponsor's protocol ID
- 10154745DOC
- Status last verified
- Oct 2019
- First submitted
- 12 Sep 2014
- Last updated
- 6 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30419603
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02347189
- Acronym / sponsor ID
- 10154745DOC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medtronic Heart ValvesIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 29 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 PB1016 | Other | Device: Melody Transcatheter Pulmonary Valve PB1016 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 Valve PB1016 | Device | Melody TPV PB1016 |
Primary outcome
Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months
Time frame: 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
5 secondary outcomes
Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year
Time frame: 1 Year
Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years
Time frame: 2 Years
Number of Subjects With Serious Procedure-related and Device-related Adverse Events
Time frame: 1 Year, 2 Years
Number of Subjects With Procedural Success
Time frame: At Time Of Procedure
Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30419603Morray 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.
Related trials for Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Recruiting
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melody Transcatheter Pulmonary Valve PB1016 in people with Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects, run by Medtronic Heart Valves at 8 sites in 4 countries.
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 6 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Austria, Canada, Spain. 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 29 Nov 2017). 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?
Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months (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 NCT02347189, which also lists 1 linked publication.
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 6 Nov 2019.