Tricuspid Valve InsufficiencyTVVADNCT03775759
Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
A study testing Tricuspid valve repair or replacement and Medical management of tricuspid regurgitation in people with Tricuspid Valve Insufficiency and Right Heart Failure, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Insufficiency, Right Heart Failure, Heart Failure
- What is being tested?
- Tricuspid valve repair or replacement and Medical management of tricuspid regurgitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2018to 15 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned LVAD implantation (either destination or bridge indication)
- 18 years of age or older
- Patients will mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study.
- Patients with moderate or graeter TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) will qualify for randomization
Who cannot join
- Previous tricuspid valve surgery
- Previous left ventricular assist device
- Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization
- Preimplant RVAD or ECMO
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an intention to treat analysis as well as an "as treated" analysis with the primary outcome being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair for these patient is currently being done for some patients, without any strong data to either support such practice or negate it.
Read the detailed description
This study is a prospective, single center, randomized trial. Up to 280 subjects will be enrolled.
Inclusion Criteria - Potential subjects must meet all inclusion criteria to participate.
- Planned LVAD implantation (either destination or bridge indication)
- 18 years of age or older
- Patients wilith mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study.
- TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) quantified as moderate or severe with normal tricuspid valve leaflets
Exclusion Criteria
- Previous tricuspid valve surgery
- Previous LVAD
- Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization
- Preimplant RVAD or ECMO
- Planned thoracotomy approach for LVAD implantation
- Pregnant women
All subjects will undergo an intraoperative transesophageal echocardiogram (TEE) to evaluate their tricuspid valve. Subjects will be randomized in the operating room. Randomization will be stratified based on preoperative right ventricle dysfunction. Subjects will be randomized 1:1 to either of the following treatment arms:
- Study arm (Arm A) - Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy
- Control arm (Arm B) - LVAD implantation plus medical therapy (the medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population)
Subjects will be monitored in the surgical and on the step down floor ICU, and follow-up data will be collected on subjects monthly from routine tests and clinic visits. This will include information on adverse events and any hospital readmissions, a quality of life questionnaire at their 6 and 12 month visit, and a six minute walk test at 3, 6, and 12 months. Cardiopulmonary exercise testing will be completed at 12 or greater months.
- Being tested
- Tricuspid valve repair or replacement, Medical management of tricuspid regurgitation
- Keywords
- Left ventricular assist device, Tricuspid regurgitation, Right heart failure
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid valve repair or replacementProcedure or surgery
Available rings used at Duke include the Tri-Ad™ Adams Tricuspid Ring by Medtronic, the TAILOR™ FLEXIBLE ANNULOPLASTY RING by St. Jude Medical/Abbott, and the Carpentier-Edwards Physio II Ring by Edwards LifeSciences. Available valves used at Duke include the Mosaic™ Mitral Orbutrator by Medtronic, the Carpentier-Edwardes PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis by Edwards LifeSciences, the On-X Mitral Valve, by CryoLife, the Carbomedics Prosthetic Heart Valve by LivaNova, and the St. Jude Medical™ Mechanical Heart Valve by St. Jude Medical/Abbott.
Medical management of tricuspid regurgitationOther
The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy Receives: Procedure: Tricuspid valve repair or replacement |
| Control arm | Active comparator | LVAD implantation plus medical therapy Receives: Other: Medical management of tricuspid regurgitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively
Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
Measured: 6 months post-operatively
Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively
Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
Measured: 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start22 Aug 2018
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, non-blinded, single center
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775759
- Sponsor's protocol ID
- Pro00072372
- Acronym
- TVVAD
- Status last verified
- Jun 2023
- First submitted
- 12 Dec 2018
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendiola Pla M, Chiang Y, Nicoara A, Poehlein E, Green CL, Gross R, Bryner BS, Schroder JN, Daneshmand MA, Russell SD, DeVore AD, Patel CB, Katz JN, Milano CA, Bishawi M. Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial. J Thorac Cardiovasc Surg. 2024 May;167(5):1810-1820.e2. doi: 10.1016/j.jtcvs.2022.10.054. Epub 2022 Nov 16.
PubMed 36639288Mendiola Pla M, Russell SD, Milano CA, Chiang Y, Kang L, Poehlein E, Green CL, Benedetti F, Billard H, Bryner BS, Schroder JN, Daneshmand MA, Nicoara A, DeVore AD, Patel CB, Bishawi M. Late follow-up for a randomized trial of surgical treatment of tricuspid valve regurgitation in patients undergoing left ventricular assist device implantation. J Thorac Cardiovasc Surg. 2025 Jul;170(1):244-253.e3. doi: 10.1016/j.jtcvs.2024.09.023. Epub 2024 Sep 21.
PubMed 39313112
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
- ClinicalTrials.gov ID
- NCT03775759
- Acronym / sponsor ID
- TVVAD / Pro00072372
- Keywords
- Left ventricular assist device, Tricuspid regurgitation, Right heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Medtronic, Abbott
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 14 Dec 2018 (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.
The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an intention to treat analysis as well as an "as treated" analysis with the primary outcome being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair for these patient is currently being done for some patients, without any strong data to either support such practice or negate it.
Detailed description
This study is a prospective, single center, randomized trial. Up to 280 subjects will be enrolled.
Inclusion Criteria - Potential subjects must meet all inclusion criteria to participate.
- Planned LVAD implantation (either destination or bridge indication)
- 18 years of age or older
- Patients wilith mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study.
- TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) quantified as moderate or severe with normal tricuspid valve leaflets
Exclusion Criteria
- Previous tricuspid valve surgery
- Previous LVAD
- Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization
- Preimplant RVAD or ECMO
- Planned thoracotomy approach for LVAD implantation
- Pregnant women
All subjects will undergo an intraoperative transesophageal echocardiogram (TEE) to evaluate their tricuspid valve. Subjects will be randomized in the operating room. Randomization will be stratified based on preoperative right ventricle dysfunction. Subjects will be randomized 1:1 to either of the following treatment arms:
- Study arm (Arm A) - Tricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy
- Control arm (Arm B) - LVAD implantation plus medical therapy (the medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population)
Subjects will be monitored in the surgical and on the step down floor ICU, and follow-up data will be collected on subjects monthly from routine tests and clinic visits. This will include information on adverse events and any hospital readmissions, a quality of life questionnaire at their 6 and 12 month visit, and a six minute walk test at 3, 6, and 12 months. Cardiopulmonary exercise testing will be completed at 12 or greater months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled, non-blinded, single center
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Procedure: Tricuspid valve repair or replacementTricuspid valve ring annuloplasty or replacement at the time of LVAD implantation plus medical therapy |
| Control arm | Active comparator | Other: Medical management of tricuspid regurgitationLVAD implantation plus medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned LVAD implantation (either destination or bridge indication)
- 18 years of age or older
- Patients will mild tricuspid regurgitation (TR) during surgical planning will be screened for meeting inclusion criteria for this study.
- Patients with moderate or graeter TR on pre-operative echo (within one week of procedure) (TTE or intraoperative TEE) will qualify for randomization
Key exclusion criteria (5 listed)
- Previous tricuspid valve surgery
- Previous left ventricular assist device
- Planned concurrent right ventricular assist device (RVAD) or extracorporeal membrane oxygenation (ECMO) at the time of LVAD operation or during the same hospitalization
- Preimplant RVAD or ECMO
- Pregnant women
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 |
|---|---|---|
| Tricuspid valve repair or replacementAvailable rings used at Duke include the Tri-Ad™ Adams Tricuspid Ring by Medtronic, the TAILOR™ FLEXIBLE ANNULOPLASTY RING by St. Jude Medical/Abbott, and the Carpentier-Edwards Physio II Ring by Edwards LifeSciences. Available valves used at Duke include the Mosaic™ Mitral Orbutrator by Medtronic, the Carpentier-Edwardes PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis by Edwards LifeSciences, the On-X Mitral Valve, by CryoLife, the Carbomedics Prosthetic Heart Valve by LivaNova, and the St. Jude Medical™ Mechanical Heart Valve by St. Jude Medical/Abbott. | Procedure or surgery | Study arm |
| Medical management of tricuspid regurgitationThe medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population. | Other | Control arm |
Primary outcome
Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively
Time frame: 6 months post-operatively
Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
Proportion of patients experiencing moderate or greater right heart failure at 12 months post-operatively
Time frame: 12 months post-operatively
Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria
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 13 Jun 2023.
- Results publication: PubMed 36639288Mendiola Pla M, Chiang Y, Nicoara A, Poehlein E, Green CL, Gross R, Bryner BS, Schroder JN, Daneshmand MA, Russell SD, DeVore AD, Patel CB, Katz JN, Milano CA, Bishawi M. Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial. J Thorac Cardiovasc Surg. 2024 May;167(5):1810-1820.e2. doi: 10.1016/j.jtcvs.2022.10.054. Epub 2022 Nov 16.
- Derived from this study: PubMed 39313112Mendiola Pla M, Russell SD, Milano CA, Chiang Y, Kang L, Poehlein E, Green CL, Benedetti F, Billard H, Bryner BS, Schroder JN, Daneshmand MA, Nicoara A, DeVore AD, Patel CB, Bishawi M. Late follow-up for a randomized trial of surgical treatment of tricuspid valve regurgitation in patients undergoing left ventricular assist device implantation. J Thorac Cardiovasc Surg. 2025 Jul;170(1):244-253.e3. doi: 10.1016/j.jtcvs.2024.09.023. Epub 2024 Sep 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricuspid valve repair or replacement and Medical management of tricuspid regurgitation in people with Tricuspid Valve Insufficiency and Right Heart Failure, run by Duke University at 1 site 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 4 inclusion and 5 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Proportion of patients experiencing moderate or greater right heart failure within 6 months post-operatively (time frame: 6 months post-operatively). 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 NCT03775759, which also lists 2 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 13 Jun 2023.