Cardiac SurgeryNCT01246947
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
A study testing Tricuspid valve repair and Mitral surgery alone in people with Cardiac Surgery and Tricuspid Valve Regurgitation, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Tricuspid Valve Regurgitation
- What is being tested?
- Tricuspid valve repair and Mitral surgery alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2017
- 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
- All patients 18-65 + older years undergoing mitral valve surgery.
- Presence of moderate or mild-moderate tricuspid regurgitation as read on any echocardiographic study performed within 6 months prior to operation. Assessment if tricuspid regurgitation will be performed using an integrative method.
- All patients referred for mitral valve surgery.
- Able to understand the consent and able to sign informal consent.
Who cannot join
- Patients under 18 years of age.
- Patient with structural/ organic tricuspid valve disease.
- Refusal/ Inability to sign informal consent form.
- Pregnant women.
- Tricuspid valve endocarditis.
- Requirement for concomitant cardiac surgery (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or coronary artery bypass surgery).
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- Cardiogenic shock at the time of randomization.
- ST segment elevation myocardial infarction requiring Intervention within 7 days prior to randomization.
- Evidence of cirrhosis or hepatic synthetic failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, School of Medicine
Baltimore, Maryland, 21201
About this study
Official title: A Prospective Randomized Trial of Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation
The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. Many patients with mitral valve disease also develop a leaky tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is determined by an ultrasound test, and the amount of leakiness is graded as: none, mild, moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve, he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain about what to do. In a recent review of thousands of patients across the nation having mitral valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve repair. Since the investigators don't know what the best approach is: to leave the moderately leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose a study to determine which approach is best. Patients having mitral valve surgery with a moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow these patients for two years and see if heart function is better among those who got their valve fixed.
Read the detailed description
Study Design:
This is a single-center prospective, randomized controlled clinical trial.
Enroll/Randomize: mitral operation alone, or mitral operation with tricuspid valve repair. Randomization will occur before operation.
Operation: The surgeon will perform mitral surgery and only those patients randomized to tricuspid valve repair will perform tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques.
- Conditions
- Cardiac Surgery, Tricuspid Valve Regurgitation
- Being tested
- Tricuspid valve repair, Mitral surgery alone
- Keywords
- Moderate Tricuspid Valve Regurgitation, Tricuspid Valve Repair, Mitral Value Surgery
- 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.
Tricuspid valve repairProcedure or surgery
Also called Tricuspid valve annuloplasty
Randomized to receive Tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques, during Mitral surgery.
Mitral surgery aloneOther
Randomized to Mitral surgery alone
| Study group | Role | What they receive |
|---|---|---|
| Mitral surgery alone | Active comparator | Mitral valve surgery randomization for no repair of the moderate tricuspid regurgitation Receives: Other: Mitral surgery alone |
| Mitral surgery w/Tricuspid valve repair | Active comparator | Mitral valve surgery with randomization to repair the moderate tricuspid regurgitation Receives: Procedure: Tricuspid valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of tricuspid regurgitation at 12 months after surgery
Standard transthoracic echocardiographic assessment of the degree of tricuspid regurgitation will be performed as described in "Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography" (Zoghbi et al, J Am Soc Echocardiography 2003; 16:777-802).
An integrative approach will be used, and patients will be categorized as having one of:
- none/trivial
- mild
- moderate
- severe Tricuspid regurgitation.
Measured: 12 months
Secondary outcomes (2)
NYHA heart failure functional status
New York Heart Association Classification (NYHA)Class Class I (Asymptomatic)No limitation of ordinary physical activity. Class II (Mild)Slight limitation. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III (Moderate)Marked limitation. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV (Severe)Unable to carry out any physical activity without discomfort.
Measured: 12 Months
NYHA heart failure functional status
New York Heart Association Classification (NYHA)Class Class I (Asymptomatic)No limitation of ordinary physical activity. Class II (Mild)Slight limitation. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III (Moderate)Marked limitation. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV (Severe)Unable to carry out any physical activity without discomfort.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- James S Gammie, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246947
- Sponsor's protocol ID
- HP-00044723
- Status last verified
- Jun 2017
- First submitted
- 22 Nov 2010
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zoghbi WA, Enriquez-Sarano M, Foster E, Grayburn PA, Kraft CD, Levine RA, Nihoyannopoulos P, Otto CM, Quinones MA, Rakowski H, Stewart WJ, Waggoner A, Weissman NJ; American Society of Echocardiography. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 2003 Jul;16(7):777-802. doi: 10.1016/S0894-7317(03)00335-3. No abstract available.
PubMed 12835667
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation
- ClinicalTrials.gov ID
- NCT01246947
- Acronym / sponsor ID
- HP-00044723
- Conditions
- Cardiac Surgery, Tricuspid Valve Regurgitation
- Keywords
- Moderate Tricuspid Valve Regurgitation, Tricuspid Valve Repair, Mitral Value Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Sep 2010 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Nov 2010 (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 mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. Many patients with mitral valve disease also develop a leaky tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is determined by an ultrasound test, and the amount of leakiness is graded as: none, mild, moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve, he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain about what to do. In a recent review of thousands of patients across the nation having mitral valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve repair. Since the investigators don't know what the best approach is: to leave the moderately leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose a study to determine which approach is best. Patients having mitral valve surgery with a moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow these patients for two years and see if heart function is better among those who got their valve fixed.
Detailed description
Study Design:
This is a single-center prospective, randomized controlled clinical trial.
Enroll/Randomize: mitral operation alone, or mitral operation with tricuspid valve repair. Randomization will occur before operation.
Operation: The surgeon will perform mitral surgery and only those patients randomized to tricuspid valve repair will perform tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitral surgery alone | Active comparator | Other: Mitral surgery aloneMitral valve surgery randomization for no repair of the moderate tricuspid regurgitation |
| Mitral surgery w/Tricuspid valve repair | Active comparator | Procedure: Tricuspid valve repairMitral valve surgery with randomization to repair the moderate tricuspid regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients 18-65 + older years undergoing mitral valve surgery.
- Presence of moderate or mild-moderate tricuspid regurgitation as read on any echocardiographic study performed within 6 months prior to operation. Assessment if tricuspid regurgitation will be performed using an integrative method.
- All patients referred for mitral valve surgery.
- Able to understand the consent and able to sign informal consent.
Key exclusion criteria (9 listed)
- Patients under 18 years of age.
- Patient with structural/ organic tricuspid valve disease.
- Refusal/ Inability to sign informal consent form.
- Pregnant women.
- Tricuspid valve endocarditis.
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 repairAlso: Tricuspid valve annuloplastyRandomized to receive Tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques, during Mitral surgery. | Procedure or surgery | Mitral surgery w/Tricuspid valve repair |
| Mitral surgery aloneRandomized to Mitral surgery alone | Other | Mitral surgery alone |
Primary outcome
The degree of tricuspid regurgitation at 12 months after surgery
Time frame: 12 months
Standard transthoracic echocardiographic assessment of the degree of tricuspid regurgitation will be performed as described in "Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography" (Zoghbi et al, J Am Soc Echocardiography 2003; 16:777-802). An integrative approach will be used, and patients will be categorized as having one of: 1. none/trivial 2. mild 3. moderate 4. severe Tricuspid regurgitation.
2 secondary outcomes
NYHA heart failure functional status
Time frame: 12 Months
NYHA heart failure functional status
Time frame: 24 Months
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 8 May 2023.
- Results publication: PubMed 12835667Zoghbi WA, Enriquez-Sarano M, Foster E, Grayburn PA, Kraft CD, Levine RA, Nihoyannopoulos P, Otto CM, Quinones MA, Rakowski H, Stewart WJ, Waggoner A, Weissman NJ; American Society of Echocardiography. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 2003 Jul;16(7):777-802. doi: 10.1016/S0894-7317(03)00335-3. No abstract available.
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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.
James S Gammie, MD principal investigator
University of Maryland, Baltimore
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 and Mitral surgery alone in people with Cardiac Surgery and Tricuspid Valve Regurgitation, run by University of Maryland, Baltimore 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 9 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 8 May 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?
The degree of tricuspid regurgitation at 12 months after surgery (time frame: 12 months). 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 NCT01246947, 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 8 May 2023.