Aortic Valve InsufficiencyNCT04035356
HAART Annuloplasty Device Valve Repair Registry
An observational study of Aortic Valve Insufficiency and Aortic Aneurysm, run by Biostable Science & Engineering at 5 sites in United States.
Trial summary
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Insufficiency, Aortic Aneurysm
- What is being tested?
- Aortic valve repair
- Type of treatment
- Medical device
- How many people
- 183 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Sep 2020to 25 Jul 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
Study population: Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device at participating centers.
Who may be able to join
- The patient underwent or is undergoing aortic valve repair using either the HAART 300 or HAART 200 Aortic Annuloplasty Device in accordance with the Instructions for Use.
- The patient has reviewed and signed the written informed consent form.
- The patient agrees to return for all follow-up evaluations for the duration of the study.
Who cannot join
- Retrospective patient that has undergone a subsequent aortic valve replacement procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Duke University
Durham, North Carolina, 27705
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
West Virginia University Heart & Vascular institute
Morgantown, West Virginia, 26506
Missouri Baptist Medical Center
St Louis, Missouri, 63131
About this study
Official title: Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice setting.
Read the detailed description
The HAART Aortic Annuloplasty Devices are three-dimensional annuloplasty rings designed to be implanted intra-annularly in the aortic valve to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with trileaflet valve morphology (HAART 300) or bicuspid valve morphology (HAART 200) with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic aneurysm.
The study is a multicenter registry study enrolling both retrospective and prospective participants. Investigators are cardiothoracic surgeons specializing in surgery of the aortic valve and aorta at facilities with suitable infrastructure to support collection of the registry study data. Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device will be enrolled. All patients known to have received the HAART 300 or HAART 200 Device at participating centers will be contacted and offered the opportunity to enroll in this registry study. Prospective participants will have evaluations prior to surgery, intraoperatively, immediately following surgery, at discharge (or within 90 days), and at 1, 3, 5, and 10 years. In addition to the follow-up clinic visits, phone contacts are scheduled at years 2,4,6, 7, 8, and 9 to maintain participant engagement as well as to ascertain if any safety events have taken place. Retrospective participants who have already received the HAART 300 or HAART 200 Device prior to study enrollment will undergo safety assessment at the time of enrollment in the study.
- Conditions
- Aortic Valve Insufficiency, Aortic Aneurysm
- Being tested
- Aortic valve repair
- Keywords
- aortic valve repair, aortic valve annuloplasty
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve repairDevice
Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery
| Study group | Role | What they receive |
|---|---|---|
| HAART 300 | HAART 300 Aortic Annuloplasty Device Receives: Device: Aortic valve repair | |
| HAART 200 | HAART 200 Aortic Annuloplasty Device Receives: Device: Aortic valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from aortic valve reoperation
A reintervention for repair or replacement of the aortic valve will be considered failure for this outcome measure
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start22 Sep 2020
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Why it stopped: The study will be merged with another one.
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 Aortic Valve 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Biostable Science & Engineering
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Scott Rankin, MD, Principal investigator, West Virginia University Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035356
- Sponsor's protocol ID
- TP-01-045
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2019
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.
PubMed 26156945Mazzitelli 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 25865762Rankin JS, Mazzitelli D, Fischlein T, Choi YH, Pirk J, Pfeiffer S, Wei LM, Badhwar V. Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results. Innovations (Phila). 2018 Jul/Aug;13(4):248-253. doi: 10.1097/IMI.0000000000000539.
PubMed 30138245
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study
- ClinicalTrials.gov ID
- NCT04035356
- Acronym / sponsor ID
- TP-01-045
- Conditions
- Aortic Valve Insufficiency, Aortic Aneurysm
- Keywords
- aortic valve repair, aortic valve annuloplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study will be merged with another one.
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Biostable Science & EngineeringIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 29 Jul 2019 (actual)
- 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.
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice setting.
Detailed description
The HAART Aortic Annuloplasty Devices are three-dimensional annuloplasty rings designed to be implanted intra-annularly in the aortic valve to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with trileaflet valve morphology (HAART 300) or bicuspid valve morphology (HAART 200) with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic aneurysm.
The study is a multicenter registry study enrolling both retrospective and prospective participants. Investigators are cardiothoracic surgeons specializing in surgery of the aortic valve and aorta at facilities with suitable infrastructure to support collection of the registry study data. Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device will be enrolled. All patients known to have received the HAART 300 or HAART 200 Device at participating centers will be contacted and offered the opportunity to enroll in this registry study. Prospective participants will have evaluations prior to surgery, intraoperatively, immediately following surgery, at discharge (or within 90 days), and at 1, 3, 5, and 10 years. In addition to the follow-up clinic visits, phone contacts are scheduled at years 2,4,6, 7, 8, and 9 to maintain participant engagement as well as to ascertain if any safety events have taken place. Retrospective participants who have already received the HAART 300 or HAART 200 Device prior to study enrollment will undergo safety assessment at the time of enrollment in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAART 300 | – | Device: Aortic valve repairHAART 300 Aortic Annuloplasty Device |
| HAART 200 | – | Device: Aortic valve repairHAART 200 Aortic Annuloplasty Device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device at participating centers.
Key inclusion criteria (3 listed)
- The patient underwent or is undergoing aortic valve repair using either the HAART 300 or HAART 200 Aortic Annuloplasty Device in accordance with the Instructions for Use.
- The patient has reviewed and signed the written informed consent form.
- The patient agrees to return for all follow-up evaluations for the duration of the study.
Key exclusion criteria (1 listed)
- Retrospective patient that has undergone a subsequent aortic valve replacement procedure.
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 |
|---|---|---|
| Aortic valve repairUse of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery | Device | HAART 200, HAART 300 |
Primary outcome
Freedom from aortic valve reoperation
Time frame: 10 years
A reintervention for repair or replacement of the aortic valve will be considered failure for this outcome measure
Results and safety
The study was stopped early (reason given: The study will be merged with another one.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 26156945Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.
- Background: 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.
- Background: PubMed 30138245Rankin JS, Mazzitelli D, Fischlein T, Choi YH, Pirk J, Pfeiffer S, Wei LM, Badhwar V. Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results. Innovations (Phila). 2018 Jul/Aug;13(4):248-253. doi: 10.1097/IMI.0000000000000539.
- 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.
J. Scott Rankin, MD principal investigator
West Virginia University Heart and Vascular Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Insufficiency and Aortic Aneurysm, run by Biostable Science & Engineering at 5 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 1 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: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early (reason given: The study will be merged with another one.). Results are not available in the source record.
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?
Freedom from aortic valve reoperation (time frame: 10 years). 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 NCT04035356, 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 9 Aug 2024.