Tricuspid Valve RegurgitationContour3DNCT01585779
Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
An observational study of Tricuspid Valve Regurgitation and Tricuspid Valve Insufficiency, run by Medtronic Cardiovascular at 3 sites in United States.
Trial summary
The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
- What is being tested?
- Contour 3D® implant for tricuspid valve repair and Tri-Ad® implant for tricuspid valve repair
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to Jun 2016
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® or Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® or Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Who may be able to join
- Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable)
- Subject indicated for a concomitant surgical repair of the TV
- Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred
Who cannot join
- Subject with a degenerative TV condition
- Subject with primary TV regurgitation
- Subject with a previous TV repair or replacement
- Subject indicated for a stand-alone TV repair
- Subject currently participating in an investigational drug or another device study
- Subject with life expectancy of less than one year
Show all 11Show fewer
- Subject is pregnant or desires to be pregnant within 12 months following implantation
- Subject is under 18 or over 85 years of age
- Subject with active endocarditis
- Subject with valvular retraction with severely reduced mobility
- Subject with a heavily calcified TV
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Mission Hospital Research Institute
Asheville, North Carolina, 28801
Florida Heart & Vascular Care at Aventura
Aventura, Florida, 33308
About this study
The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.
Read the detailed description
The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial size and right ventricular function. Additionally, this study will characterize the patient population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.
- Being tested
- Contour 3D® implant for tricuspid valve repair, Tri-Ad® implant for tricuspid valve repair
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contour 3D® implant for tricuspid valve repairDevice
Tricuspid annuloplasty ring
Tri-Ad® implant for tricuspid valve repairDevice
Tricuspid annuloplasty ring
| Study group | Role | What they receive |
|---|---|---|
| Contour 3D® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Receives: Device: Contour 3D® implant for tricuspid valve repair | |
| Tri-Ad® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Receives: Device: Tri-Ad® implant for tricuspid valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Degree of Tricuspid Regurgitation
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.
Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Measured: Preimplant through Discharge
Change in the Degree of Tricuspid Regurgitation
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.
Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Measured: Preimplant through 6 Months
Change in the Degree of Tricuspid Regurgitation
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.
Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Measured: Preimplant through 12 Months
The Mean Gradient Across the Tricuspid Valve
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Measured: Discharge
The Mean Gradient Across the Tricuspid Valve
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Measured: 6 months
The Mean Gradient Across the Tricuspid Valve
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Measured: 12 months
Change in the Degree of TV Leaflet Coaptation Length
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Measured: Preimplant through Discharge
Change in the Degree of TV Leaflet Coaptation Length
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Measured: Preimplant through 6 Months
Change in the Degree of TV Leaflet Coaptation Length
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Measured: Preimplant through 12 Months
Change in the Degree of TV Leaflet Tethering Height
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.
Measured: Preimplant through Discharge
Change in the Degree of TV Leaflet Tethering Height
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.
Measured: Preimplant through 6 Months
Change in the Degree of TV Leaflet Tethering Height
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant
Measured: Preimplant through 12 Months
Secondary outcomes (13)
Change in the Right Ventricle (RV) Diastolic Area
The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.
Measured: Preimplant through Discharge
Change in the Right Ventricle (RV) Diastolic Area
The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.
Measured: Preimplant through 6 Months
Change in the Right Ventricle (RV) Diastolic Area
The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant
Measured: Preimplant through 12 Months
Change in the Tricuspid Annular (Basal) Diameter
The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant
Measured: Preimplant through Discharge
Change in the Tricuspid Annular (Basal) Diameter
The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant
Measured: Preimplant through 6 Months
Change in the Tricuspid Annular (Basal) Diameter
The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant
Measured: Preimplant through 12 Months
Change in the RV Fractional Area
The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.
Measured: Preimplant through Discharge
Change in the RV Fractional Area
The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.
Measured: Preimplant through 6 Months
Change in the RV Fractional Area
The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.
Measured: Preimplant through 12 Months
Demographic Data
Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status
Measured: Baseline
Change in New York Heart Association (NYHA) Classification
Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.
Measured: Preimplant through Discharge
Change in New York Heart Association (NYHA) Classification
Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.
Measured: Preimplant through 6 months
Change in New York Heart Association (NYHA) Classification .
Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.
Measured: Preimplant through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2016
- Study completionJun 2016
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.
- Other trials for Tricuspid Valve RegurgitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Vang, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585779
- Sponsor's protocol ID
- 10030481DOC
- Acronym
- Contour3D
- Status last verified
- May 2017
- First submitted
- 18 Apr 2012
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
- ClinicalTrials.gov ID
- NCT01585779
- Acronym / sponsor ID
- Contour3D / 10030481DOC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 10 May 2017
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 gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.
Detailed description
The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial size and right ventricular function. Additionally, this study will characterize the patient population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contour 3D® Implant | – | Device: Contour 3D® implant for tricuspid valve repairThe subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure |
| Tri-Ad® Implant | – | Device: Tri-Ad® implant for tricuspid valve repairThe subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® or Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® or Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Key inclusion criteria (3 listed)
- Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable)
- Subject indicated for a concomitant surgical repair of the TV
- Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred
Key exclusion criteria (11 listed)
- Subject with a degenerative TV condition
- Subject with primary TV regurgitation
- Subject with a previous TV repair or replacement
- Subject indicated for a stand-alone TV repair
- Subject currently participating in an investigational drug or another device study
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 |
|---|---|---|
| Contour 3D® implant for tricuspid valve repairTricuspid annuloplasty ring | Device | Contour 3D® Implant |
| Tri-Ad® implant for tricuspid valve repairTricuspid annuloplasty ring | Device | Tri-Ad® Implant |
Primary outcome
Change in the Degree of Tricuspid Regurgitation
Time frame: Preimplant through Discharge
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Change in the Degree of Tricuspid Regurgitation
Time frame: Preimplant through 6 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Change in the Degree of Tricuspid Regurgitation
Time frame: Preimplant through 12 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
The Mean Gradient Across the Tricuspid Valve
Time frame: Discharge
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
The Mean Gradient Across the Tricuspid Valve
Time frame: 6 months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
The Mean Gradient Across the Tricuspid Valve
Time frame: 12 months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Change in the Degree of TV Leaflet Coaptation Length
Time frame: Preimplant through Discharge
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Change in the Degree of TV Leaflet Coaptation Length
Time frame: Preimplant through 6 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Change in the Degree of TV Leaflet Coaptation Length
Time frame: Preimplant through 12 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Change in the Degree of TV Leaflet Tethering Height
Time frame: Preimplant through Discharge
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.
Change in the Degree of TV Leaflet Tethering Height
Time frame: Preimplant through 6 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.
Change in the Degree of TV Leaflet Tethering Height
Time frame: Preimplant through 12 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant
13 secondary outcomes
Change in the Right Ventricle (RV) Diastolic Area
Time frame: Preimplant through Discharge
Change in the Right Ventricle (RV) Diastolic Area
Time frame: Preimplant through 6 Months
Change in the Right Ventricle (RV) Diastolic Area
Time frame: Preimplant through 12 Months
Change in the Tricuspid Annular (Basal) Diameter
Time frame: Preimplant through Discharge
Change in the Tricuspid Annular (Basal) Diameter
Time frame: Preimplant through 6 Months
Change in the Tricuspid Annular (Basal) Diameter
Time frame: Preimplant through 12 Months
Change in the RV Fractional Area
Time frame: Preimplant through Discharge
Change in the RV Fractional Area
Time frame: Preimplant through 6 Months
Change in the RV Fractional Area
Time frame: Preimplant through 12 Months
Demographic Data
Time frame: Baseline
Change in New York Heart Association (NYHA) Classification
Time frame: Preimplant through Discharge
Change in New York Heart Association (NYHA) Classification
Time frame: Preimplant through 6 months
Change in New York Heart Association (NYHA) Classification .
Time frame: Preimplant through 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor websiteLink provided by the sponsor.
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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.
Eric Vang study director
Medtronic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Valve Regurgitation and Tricuspid Valve Insufficiency, run by Medtronic Cardiovascular at 3 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 3 inclusion and 11 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 10 May 2017. 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. 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 10 May 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?
Change in the Degree of Tricuspid Regurgitation (time frame: Preimplant through Discharge). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2017.