Congenital Heart DiseaseNCT01762124
Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)
A study testing Native Outflow Tract TPV in people with Congenital Heart Disease and Tetralogy of Fallot, run by Medtronic Heart Valves at 3 sites in 2 countries.
Trial summary
The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Tetralogy of Fallot
- What is being tested?
- Native Outflow Tract TPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2012to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject has pulmonary regurgitation as per one or more of the following criteria: Severe pulmonary regurgitation as measured by Doppler echocardiography, or Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging
- Clinical indication for surgical placement of a RVOT conduit or bioprosthetic pulmonary valve per one or more of the following criteria: Subject is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the Investigator, or Right ventricular end diastolic volume (RVEDV) ≥ 150 ml/m2
- Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements
Who cannot join
- Anatomy unable to accommodate a 25 Fr delivery system
- Obstruction of the central veins
- Clinical or biological signs of infection including active endocarditis
- Indicated for intervention of stenosis of the branch pulmonary arteries at time of implant
- Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential
- Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a right ventricle-to-pulmonary artery conduit implant
Show all 13Show fewer
- 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 Native Outflow Tract TPV in the left heart
- RVOT anatomy or morphology that is unfavorable for anchoring
- 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
- Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.
Read the detailed description
Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device.
- Conditions
- Congenital Heart Disease, Tetralogy of Fallot
- Being tested
- Native Outflow Tract TPV
- Keywords
- Pulmonary valve, Congenital heart disease, Transcatheter pulmonary valve, Percutaneous pulmonary valve
- Medical subject headings
- Heart Defects, Congenital, Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native Outflow Tract TPVDevice
Also called Native TPV
Transcatheter placement of a pulmonary valve
| Study group | Role | What they receive |
|---|---|---|
| Native Outflow Tract TPV | Experimental | Implantation of the Native Outflow Tract TPV Receives: Device: Native Outflow Tract TPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of radial, linear and axial compression, bending and torsion of device
The following variables will be measured: radial compression, linear compression, axial compression, device bending and device torsion using the discharge CT. The degree of deformation of the device will be reported.
Measured: 4 Days Post-Implant
Secondary outcomes (11)
Number of Patients with Procedural Success
The number of patients who are successfully implanted with the device will be reported. This is measured by meeting all of the following criteria: Confirmation that the device is fixated within the desired location, RV-PA peak-to-peak gradient is less than 25 mmHg, Pulmonary regurgitation is moderate or less, and the subject is free of explantation at 24 hours post-implant.
Measured: 24 hours post-implant
Number of Patients with Serious Procedural Adverse Events
The number of patients that experience a serious procedural adverse event, as defined per the study protocol, will be reported.
Measured: Through 5 year follow-up
Number of Patients with Device-related Adverse Events
The number of patients that experience a device-related adverse event, as defined per the study protocol, will be reported.
Measured: Through 5 years
Number of Patients with Stent Fracture
The number of patients that experience a stent fracture of their device will be reported.
Measured: Through 5 years
Number of Patients with Catheter Re-intervention on the TPV
The number of patients that experience a catheter re-intervention will be reported.
Measured: Through 5 years
Assessment of Surgical Intervention on the TPV
The number of patients that undergo a surgical intervention will be reported.
Measured: Through 5 years
Number of Patient Deaths (all-cause, procedural, and device-related)
Any patient deaths that occur during the study will be reported.
Measured: Through 5 years
Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI
The pulmonary regurgitant fraction for all patients, as measured by cardiac MRI, will be reported.
Measured: Through 5 years
Pulmonary Regurgitation Severity as Measured by Echocardiography
The pulmonary regurgitation severity for all patients, as measured by echocardiography, will be reported.
Measured: Through 5 years
Right Ventricular Volume (ml) as Measured by Cardiac MRI
The right ventricular volumes for all patients, as measured by cardiac MRI, will be reported.
Measured: Through 5 years
Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler
The mean RVOT gradient for all patients, as measured by Color Wave Doppler, will be reported.
Measured: Through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Heart Valves
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee Benson, MD, Principal investigator, The Hospital for Sick Children, Toronto, CanadaJohn P. Cheatham, MD, Principal investigator, Nationwide Children's HospitalLisa Bergersen, MD, MPH, Principal investigator, Boston Children's Hospital, Boston, Massachusetts, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762124
- Sponsor's protocol ID
- 10022972DOC
- Status last verified
- Aug 2020
- First submitted
- 30 Nov 2012
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Morray BH, Gillespie MJ, Cheatham JP, Salavitabar A, Peng L, Jones TK, Levi DS, Gray RG, Asnes J, Cabalka AK, Fujimoto K, Qureshi AM, Bergersen L, Benson LN, Haugan D, McElhinney DB. Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients. Circ Cardiovasc Interv. 2025 Sep;18(9):e015196. doi: 10.1161/CIRCINTERVENTIONS.125.015196. Epub 2025 Jul 16.
PubMed 40665900Gillespie MJ, Bergersen L, Benson LN, Weng S, Cheatham JP. 5-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. JACC Cardiovasc Interv. 2021 Apr 12;14(7):816-817. doi: 10.1016/j.jcin.2021.01.046. No abstract available.
PubMed 33826508Benson LN, Gillespie MJ, Bergersen L, Cheatham SL, Hor KN, Horlick EM, Weng S, McHenry BT, Osten MD, Powell AJ, Cheatham JP. Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. Circ Cardiovasc Interv. 2020 Jan;13(1):e008320. doi: 10.1161/CIRCINTERVENTIONS.119.008320. Epub 2020 Jan 9.
PubMed 32525412
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
- ClinicalTrials.gov ID
- NCT01762124
- Acronym / sponsor ID
- 10022972DOC
- Conditions
- Congenital Heart Disease, Tetralogy of Fallot
- Keywords
- Pulmonary valve, Congenital heart disease, Transcatheter pulmonary valve, Percutaneous pulmonary valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medtronic Heart ValvesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
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 early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.
Detailed description
Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Native Outflow Tract TPV | Experimental | Device: Native Outflow Tract TPVImplantation of the Native Outflow Tract TPV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has pulmonary regurgitation as per one or more of the following criteria: Severe pulmonary regurgitation as measured by Doppler echocardiography, or Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging
- Clinical indication for surgical placement of a RVOT conduit or bioprosthetic pulmonary valve per one or more of the following criteria: Subject is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the Investigator, or Right ventricular end diastolic volume (RVEDV) ≥ 150 ml/m2
- Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements
Key exclusion criteria (13 listed)
- Anatomy unable to accommodate a 25 Fr delivery system
- Obstruction of the central veins
- Clinical or biological signs of infection including active endocarditis
- Indicated for intervention of stenosis of the branch pulmonary arteries at time of implant
- Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential
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 |
|---|---|---|
| Native Outflow Tract TPVAlso: Native TPVTranscatheter placement of a pulmonary valve | Device | Native Outflow Tract TPV |
Primary outcome
Measurement of radial, linear and axial compression, bending and torsion of device
Time frame: 4 Days Post-Implant
The following variables will be measured: radial compression, linear compression, axial compression, device bending and device torsion using the discharge CT. The degree of deformation of the device will be reported.
11 secondary outcomes
Number of Patients with Procedural Success
Time frame: 24 hours post-implant
Number of Patients with Serious Procedural Adverse Events
Time frame: Through 5 year follow-up
Number of Patients with Device-related Adverse Events
Time frame: Through 5 years
Number of Patients with Stent Fracture
Time frame: Through 5 years
Number of Patients with Catheter Re-intervention on the TPV
Time frame: Through 5 years
Assessment of Surgical Intervention on the TPV
Time frame: Through 5 years
Number of Patient Deaths (all-cause, procedural, and device-related)
Time frame: Through 5 years
Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI
Time frame: Through 5 years
Pulmonary Regurgitation Severity as Measured by Echocardiography
Time frame: Through 5 years
Right Ventricular Volume (ml) as Measured by Cardiac MRI
Time frame: Through 5 years
Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler
Time frame: Through 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 40665900Morray BH, Gillespie MJ, Cheatham JP, Salavitabar A, Peng L, Jones TK, Levi DS, Gray RG, Asnes J, Cabalka AK, Fujimoto K, Qureshi AM, Bergersen L, Benson LN, Haugan D, McElhinney DB. Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients. Circ Cardiovasc Interv. 2025 Sep;18(9):e015196. doi: 10.1161/CIRCINTERVENTIONS.125.015196. Epub 2025 Jul 16.
- Derived from this study: PubMed 33826508Gillespie MJ, Bergersen L, Benson LN, Weng S, Cheatham JP. 5-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. JACC Cardiovasc Interv. 2021 Apr 12;14(7):816-817. doi: 10.1016/j.jcin.2021.01.046. No abstract available.
- Derived from this study: PubMed 32525412Benson LN, Gillespie MJ, Bergersen L, Cheatham SL, Hor KN, Horlick EM, Weng S, McHenry BT, Osten MD, Powell AJ, Cheatham JP. Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. Circ Cardiovasc Interv. 2020 Jan;13(1):e008320. doi: 10.1161/CIRCINTERVENTIONS.119.008320. Epub 2020 Jan 9.
- Individual participant dataSharing planned: No
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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.
Lee Benson, MD principal investigator
The Hospital for Sick Children, Toronto, Canada
John P. Cheatham, MD principal investigator
Nationwide Children's Hospital
Lisa Bergersen, MD, MPH principal investigator
Boston Children's Hospital, Boston, Massachusetts, USA
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native Outflow Tract TPV in people with Congenital Heart Disease and Tetralogy of Fallot, run by Medtronic Heart Valves at 3 sites in 2 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 3 inclusion and 13 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 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of radial, linear and axial compression, bending and torsion of device (time frame: 4 Days Post-Implant). 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 NCT01762124, 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 7 Aug 2020.