Aortic InsufficiencyNCT02071849
HAART 200 Aortic Valve Annuloplasty Trial
A study testing HAART 200 Aortic Valve Annuloplasty Device in people with Aortic Insufficiency, run by Biostable Science & Engineering at 4 sites in Germany.
Trial summary
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Insufficiency
- What is being tested?
- HAART 200 Aortic Valve Annuloplasty Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesGermany
- Study dates
- Sep 2013to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 18 years of age or older
- The subject has bi-leaflet aortic valve morphology
- The subject has documented aortic valve disease which may or may not include:
- Aortic valve insufficiency
- Ascending aortic or aortic root pathology
- Other pathology of the ascending aorta that requires elective aortic replacement
Show all 16Show fewer
- Associated stable one or two vessel coronary disease requiring concomitant coronary bypass
- Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who are undergoing re-repair because of annular re-dilatation
- All bicuspid annular and leaflet configurations will be included
- The subject needs:
- correction of BAV annular dilatation in patients with chronic AI and dilated annulus
- restoration of a circular annular shape in patients with bicuspid valve and expansion of sinus to sinus dimensions
- stabilization of annular geometry long-term in rare bicuspid valve patients with severe AI and minimal annular dilatation
- The is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
- The subject has reviewed and signed the written informed consent form
- The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable)
Who cannot join
- All patients will be excluded who require emergency surgery for any reason.
- All the patients who have had a prior heart valve replacement
- The subject's aortic valve morphology is not bicuspid.
- The subject has active endocarditis
- The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
- Heavily calcified BAV valves, calcified aortic roots, or "porcelain aortas"
Show all 22Show fewer
- Leukopenia with a White Blood Cell (WBC) of less than 3000
- Acute anemia with a Hgb less than 9mg%
- Platelet count less than 100,000 cells/mm3
- History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions
- Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics)
- Subjects in whom transesophageal echocardiography (TEE) is contraindicated
- Low Ejection Fraction (EF) < 35%
- Life expectancy < 1 year, or severe comorbidities, such as dialysis or severe Chronic Obstructive Pulmonary Disease (COPD)
- The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
- The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
- The subject is pregnant or lactating
- Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
- Myocardial Infarction (MI) within one month of trial inclusion
- The subject has a known intolerance to titanium or polyester
- The subject has documented unstable or > 2 vessel coronary disease
- The subject requires additional valve replacement or valve repair
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
Klinik und Poliklinik für Herz- und Gefäßchirurgie
Hamburg, 20246
München Heart Center
München, Bavaria, 80636
Klinikum Nürnberg Süd
Nuremberg, 90471
About this study
Official title: HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).
Read the detailed description
Aortic valve disease is the most common valvular heart disease with approximately 200,000 patients per year undergoing conventional aortic valve replacement in North America and Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency, which is the failure of the aortic valve to close completely during diastole, causing blood to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in a fourth to a third of patients coming to surgical intervention, and constitutes a very important subset. Several conditions are associated with bicuspid disease, including ascending aortic or root aneurysms in up to a third.
Traditional management of aortic valve and root disease has been with aortic valve replacement, with or without root replacement (Bentall Procedure). However, as has been observed in patients with mitral valve repair, the option of maintaining one's reconstructed native valve versus a replacement, either bioprosthetic or mechanical, can have multiple benefits. The advantages of repair include: the avoidance of prosthetic valve related complications and structural degeneration with bioprosthetic valves over 10-15 years and elimination of the need for anticoagulation and related problems with mechanical valves in younger patients. The significantly lower rate of endocarditis after repair is a major impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently is established as an excellent option for patients with BAV. However, with connective tissue disorders being an inherent feature of BAV, outcomes have been less stable long-term than for trileaflet repair, primarily because of late annular redilatation in BAV disease.
Therefore, this study is designed to evaluate the safety and effectiveness of annular stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid aortic valve for predominant aortic insufficiency.
- Conditions
- Aortic Insufficiency
- Being tested
- HAART 200 Aortic Valve Annuloplasty Device
- Keywords
- Aortic Insufficiency, Aortic Regurgitation
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAART 200 Aortic Valve Annuloplasty DeviceDevice
Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
| Study group | Role | What they receive |
|---|---|---|
| Aortic Valve Repair | Experimental | Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction Receives: Device: HAART 200 Aortic Valve Annuloplasty Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.
Measured: 6 months postprocedure
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)
Measured: 6 months postprocedure
Secondary outcomes (27)
Implant Procedure Success
Success is defined as the absence of specified adverse events evaluated through discharge following the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.
Measured: discharge or 14 days postprocedure, whichever comes first
Actuarial Freedom From Clinical Cardiovascular Events
Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months
Measured: 6 months postprocedure
Actuarial Freedom From Clinical Cardiovascular Events
Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months
Measured: 2 years postprocedure
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.
Measured: 2 years
Aortic Insufficiency (AI) at 2 Years
Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Measured: Baseline and 2 years
New York Heart Association (NYHA) Functional Capacity Classification
Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
Measured: 6 months postprocedure
NYHA Functional Capacity Classification
Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
Measured: 2 years postprocedure
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 6 months
Peak Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 2 years
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 6 months
Mean Gradient - Change From Baseline
Transthoracic echocardiography parameter
Measured: Baseline and 2 years
Left Ventricular (LV) Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LV Mass - Change From Baseline
Left ventricular mass. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LVID Diastole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LVID Systole - Change From Baseline
Left ventricular internal dimension. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LV Diastolic Volume - Change From Baseline
Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
LV Systolic Volume - Change From Baseline
Left ventricular systolic volume. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Measured: Baseline and 6 months
Cardiac Output - Change From Baseline
Stroke volume x heart rate. Transthoracic echocardiography parameter.
Measured: Baseline and 2 years
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Measured: Baseline and 6 months
Cardiac Index - Change From Baseline
Hemodynamic parameter computed as cardiac output divided by body surface area
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionApr 2015
- Study completionAug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic InsufficiencyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biostable Science & Engineering
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominico Mazzitelli, MD, Principal investigator, München Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071849
- Sponsor's protocol ID
- TP-01-025
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2014
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10.
PubMed 25865762
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial
- ClinicalTrials.gov ID
- NCT02071849
- Acronym / sponsor ID
- TP-01-025
- Conditions
- Aortic Insufficiency
- Keywords
- Aortic Insufficiency, Aortic Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Biostable Science & EngineeringIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).
Detailed description
Aortic valve disease is the most common valvular heart disease with approximately 200,000 patients per year undergoing conventional aortic valve replacement in North America and Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency, which is the failure of the aortic valve to close completely during diastole, causing blood to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in a fourth to a third of patients coming to surgical intervention, and constitutes a very important subset. Several conditions are associated with bicuspid disease, including ascending aortic or root aneurysms in up to a third.
Traditional management of aortic valve and root disease has been with aortic valve replacement, with or without root replacement (Bentall Procedure). However, as has been observed in patients with mitral valve repair, the option of maintaining one's reconstructed native valve versus a replacement, either bioprosthetic or mechanical, can have multiple benefits. The advantages of repair include: the avoidance of prosthetic valve related complications and structural degeneration with bioprosthetic valves over 10-15 years and elimination of the need for anticoagulation and related problems with mechanical valves in younger patients. The significantly lower rate of endocarditis after repair is a major impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently is established as an excellent option for patients with BAV. However, with connective tissue disorders being an inherent feature of BAV, outcomes have been less stable long-term than for trileaflet repair, primarily because of late annular redilatation in BAV disease.
Therefore, this study is designed to evaluate the safety and effectiveness of annular stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid aortic valve for predominant aortic insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic Valve Repair | Experimental | Device: HAART 200 Aortic Valve Annuloplasty DeviceImplantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subject is 18 years of age or older
- The subject has bi-leaflet aortic valve morphology
- The subject has documented aortic valve disease which may or may not include:
- The subject needs:
- The is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
Key exclusion criteria (22 listed)
- All patients will be excluded who require emergency surgery for any reason.
- All the patients who have had a prior heart valve replacement
- The subject's aortic valve morphology is not bicuspid.
- The subject has active endocarditis
- The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
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 |
|---|---|---|
| HAART 200 Aortic Valve Annuloplasty DeviceSurgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device . | Device | Aortic Valve Repair |
Primary outcome
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.
Time frame: 6 months postprocedure
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Time frame: 6 months postprocedure
Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)
27 secondary outcomes
Implant Procedure Success
Time frame: discharge or 14 days postprocedure, whichever comes first
Actuarial Freedom From Clinical Cardiovascular Events
Time frame: 6 months postprocedure
Actuarial Freedom From Clinical Cardiovascular Events
Time frame: 2 years postprocedure
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.
Time frame: 2 years
Aortic Insufficiency (AI) at 2 Years
Time frame: Baseline and 2 years
New York Heart Association (NYHA) Functional Capacity Classification
Time frame: 6 months postprocedure
NYHA Functional Capacity Classification
Time frame: 2 years postprocedure
Peak Gradient - Change From Baseline
Time frame: Baseline and 6 months
Peak Gradient - Change From Baseline
Time frame: Baseline and 2 years
Mean Gradient - Change From Baseline
Time frame: Baseline and 6 months
Mean Gradient - Change From Baseline
Time frame: Baseline and 2 years
Left Ventricular (LV) Mass - Change From Baseline
Time frame: Baseline and 6 months
LV Mass - Change From Baseline
Time frame: Baseline and 2 years
Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline
Time frame: Baseline and 6 months
LVID Diastole - Change From Baseline
Time frame: Baseline and 2 years
LVID Systole - Change From Baseline
Time frame: Baseline and 6 months
LVID Systole - Change From Baseline
Time frame: Baseline and 2 years
LV Diastolic Volume - Change From Baseline
Time frame: Baseline and 6 months
LV Diastolic Volume - Change From Baseline
Time frame: Baseline and 2 years
LV Systolic Volume - Change From Baseline
Time frame: Baseline and 6 months
LV Systolic Volume - Change From Baseline
Time frame: Baseline and 2 years
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
Time frame: Baseline and 6 months
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
Time frame: Baseline and 2 years
Cardiac Output - Change From Baseline
Time frame: Baseline and 6 months
Cardiac Output - Change From Baseline
Time frame: Baseline and 2 years
Cardiac Index - Change From Baseline
Time frame: Baseline and 6 months
Cardiac Index - Change From Baseline
Time frame: Baseline and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25865762Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10.
- Individual participant dataSharing planned: Undecided
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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.
Dominico Mazzitelli, MD principal investigator
München Heart Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAART 200 Aortic Valve Annuloplasty Device in people with Aortic Insufficiency, run by Biostable Science & Engineering at 4 sites in Germany.
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 16 inclusion and 22 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 20 Mar 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?
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure. (time frame: 6 months postprocedure). The study lists 2 primary outcomes in all. 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 NCT02071849, 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 17 Apr 2017.