Functional Tricuspid RegurgitationNCT04078867
Outcome of MC3 Ring Annuloplasty for Functional Tricuspid Regurgitation
An observational study of Functional Tricuspid Regurgitation, run by Minia University.
Trial summary
This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and December 2018, a group of 23 patients underwent ring annuloplasty with Edward MC3 rings were compared to another group of 82 patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Tricuspid Regurgitation
- What is being tested?
- tricuspid valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2018
- How long will I take part?
- 3 Months
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent repair for functional tricuspid regurgitation during mitral valve replacement for rheumatic valve disease
Who may be able to join
- Rheumatic mitral valve disease
- Surgery for mitral valve replacement
- Severe functional tricuspid regurgitation
- Moderate functional tricuspid regurgitation with annular dilatation > 40 mm
- Moderate functional tricuspid regurgitation with preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg
Who cannot join
- Patients with non-rheumatic mitral disease
- Combined mitral and aortic valve replacement
- Mitral valve repair
- Concomitant coronary artery or aortic surgery
- Mild or organic tricuspid regurgitation
- Emergency surgery
- Reoperations
- Invalid or missed data
About this study
Official title: Outcome of MC3 Ring Annuloplasty for Moderate and Severe Functional Tricuspid Regurgitation Associated With Rheumatic Mitral Valve Disease
This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and December 2018, a group of 23 patients underwent ring annuloplasty with Edward MC3 rings were compared to another group of 82 patients underwent standard suture (DeVega) repair. The primary outcome was residual TR (≥ moderate TR).
Read the detailed description
This study evaluated early and midterm outcomes after operations for TV repair which were performed at our institution, between January 2016 and December 2018. The mean follow-up duration was 18.84±9.90 months (range: 3-33 months). The study included 105 patients who underwent repair for FTR during mitral valve replacement for rheumatic valve disease. There were 82 patients underwent suture (DeVega) repair and 23 patients underwent ring annuloplasty using Edward MC3 incomplete 3D ring. The indications of surgery for FTR were: (1) severe TR; or (2) moderate TR with annular dilatation greater than 40 mm and/or preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg. We excluded patients with non-rheumatic mitral disease, combined mitral and aortic valve replacement, mitral valve repair, concomitant coronary artery or aortic surgery, mild or organic tricuspid regurgitation, emergency surgery, reoperations or missed data. Based on echocardiographic data, the severity of TR was graded as: 0 (no TR), 1+ (mild TR), 2+ (mild to moderate TR), 3+ (moderately severe TR), or 4+ (severe).
The type of tricuspid valve repair was chosen in according to surgeon's preference and echocardiographic criteria of TV. The DeVega repair was performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension, while ring annuloplasty was performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension. The DeVega repair was performed on a beating heart using pledget-supported two 4-0 polypropylene running parallel sutures. The MC3 ring annuloplasty was performed through right atriotomy using cardiopulmonary bypass and cardioplegic arrest. The ring size was determined after measurement of the length of the attachments of the tricuspid septal leaflet (the distance between the anteroseptal and septoposterior commissures) or the surface area of the anterior leaflet. The chosen ring was undersized by at least one size. The ring was implanted from the anteroseptal commissure to the middle of the septal leaflet. A series of 8 to10 mattress sutures with a 2-0 Ethibond multifilament suture were made on the tricuspid annulus starting from the center of the septal annulus to the anteroseptal commissure in the counter-clockwise direction, to avoid the atrioventricular conduction tissue. Thereafter, the sutures were placed through the sewing ring of the prosthesis , followed by lowering and securing of the ring to the annulus The collected pre-operative data included age, sex, New York Heart Association (NYHA) functional class, , and the type of preoperative mitral valve disease. The primarily assessed post-operative outcome was residual TR (≥ moderate TR; ≥ grade +2). Other assessed pre- and post-operative parameters included NYHA functional class, and echocardiographic data regarding grade of TR, SPAP, tricuspid annulus (TA) diameter, tricuspid annular plane systolic excursion (TAPSE), left atrial diameter (LAD), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), and left ventricular ejection fraction (LVEF).
- Conditions
- Functional Tricuspid Regurgitation
- Being tested
- tricuspid valve repair
- Keywords
- Tricuspid valve, Functional tricuspid regurgitation, Suture annuloplasty, Ring annuloplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tricuspid valve repairProcedure or surgery
Tricuspid valve repair during mitral valve replacement for rheumatic heart disease using suture (DeVega) repair or ring annuloplasty
| Study group | Role | What they receive |
|---|---|---|
| DeVega | The DeVega repair is performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension Receives: Procedure: tricuspid valve repair | |
| MC3 ring | MC3 ring annuloplasty is performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension Receives: Procedure: tricuspid valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual tricuspid regirgitation (TR)
residual TR is defined when there is moderate or above degree of TR at the last follow-up echocardiography of the patient
Measured: 3-33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Minia 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Ali Kamal, Minia University
- Investigators
- Yasser A Kamal, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078867
- Sponsor's protocol ID
- 62-15
- Status last verified
- Sep 2019
- First submitted
- 31 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of MC3 Ring Annuloplasty for Moderate and Severe Functional Tricuspid Regurgitation Associated With Rheumatic Mitral Valve Disease
- ClinicalTrials.gov ID
- NCT04078867
- Acronym / sponsor ID
- 62-15
- Conditions
- Functional Tricuspid Regurgitation
- Keywords
- Tricuspid valve, Functional tricuspid regurgitation, Suture annuloplasty, Ring annuloplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Sep 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.
This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and December 2018, a group of 23 patients underwent ring annuloplasty with Edward MC3 rings were compared to another group of 82 patients underwent standard suture (DeVega) repair. The primary outcome was residual TR (≥ moderate TR).
Detailed description
This study evaluated early and midterm outcomes after operations for TV repair which were performed at our institution, between January 2016 and December 2018. The mean follow-up duration was 18.84±9.90 months (range: 3-33 months). The study included 105 patients who underwent repair for FTR during mitral valve replacement for rheumatic valve disease. There were 82 patients underwent suture (DeVega) repair and 23 patients underwent ring annuloplasty using Edward MC3 incomplete 3D ring. The indications of surgery for FTR were: (1) severe TR; or (2) moderate TR with annular dilatation greater than 40 mm and/or preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg. We excluded patients with non-rheumatic mitral disease, combined mitral and aortic valve replacement, mitral valve repair, concomitant coronary artery or aortic surgery, mild or organic tricuspid regurgitation, emergency surgery, reoperations or missed data. Based on echocardiographic data, the severity of TR was graded as: 0 (no TR), 1+ (mild TR), 2+ (mild to moderate TR), 3+ (moderately severe TR), or 4+ (severe).
The type of tricuspid valve repair was chosen in according to surgeon's preference and echocardiographic criteria of TV. The DeVega repair was performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension, while ring annuloplasty was performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension. The DeVega repair was performed on a beating heart using pledget-supported two 4-0 polypropylene running parallel sutures. The MC3 ring annuloplasty was performed through right atriotomy using cardiopulmonary bypass and cardioplegic arrest. The ring size was determined after measurement of the length of the attachments of the tricuspid septal leaflet (the distance between the anteroseptal and septoposterior commissures) or the surface area of the anterior leaflet. The chosen ring was undersized by at least one size. The ring was implanted from the anteroseptal commissure to the middle of the septal leaflet. A series of 8 to10 mattress sutures with a 2-0 Ethibond multifilament suture were made on the tricuspid annulus starting from the center of the septal annulus to the anteroseptal commissure in the counter-clockwise direction, to avoid the atrioventricular conduction tissue. Thereafter, the sutures were placed through the sewing ring of the prosthesis , followed by lowering and securing of the ring to the annulus The collected pre-operative data included age, sex, New York Heart Association (NYHA) functional class, , and the type of preoperative mitral valve disease. The primarily assessed post-operative outcome was residual TR (≥ moderate TR; ≥ grade +2). Other assessed pre- and post-operative parameters included NYHA functional class, and echocardiographic data regarding grade of TR, SPAP, tricuspid annulus (TA) diameter, tricuspid annular plane systolic excursion (TAPSE), left atrial diameter (LAD), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), and left ventricular ejection fraction (LVEF).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DeVega | – | Procedure: tricuspid valve repairThe DeVega repair is performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension |
| MC3 ring | – | Procedure: tricuspid valve repairMC3 ring annuloplasty is performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent repair for functional tricuspid regurgitation during mitral valve replacement for rheumatic valve disease
Key inclusion criteria (5 listed)
- Rheumatic mitral valve disease
- Surgery for mitral valve replacement
- Severe functional tricuspid regurgitation
- Moderate functional tricuspid regurgitation with annular dilatation > 40 mm
- Moderate functional tricuspid regurgitation with preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg
Key exclusion criteria (8 listed)
- Patients with non-rheumatic mitral disease
- Combined mitral and aortic valve replacement
- Mitral valve repair
- Concomitant coronary artery or aortic surgery
- Mild or organic tricuspid regurgitation
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 repairTricuspid valve repair during mitral valve replacement for rheumatic heart disease using suture (DeVega) repair or ring annuloplasty | Procedure or surgery | DeVega, MC3 ring |
Primary outcome
Residual tricuspid regirgitation (TR)
Time frame: 3-33 months
residual TR is defined when there is moderate or above degree of TR at the last follow-up echocardiography of the patient
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 6 Sep 2019.
- 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.
Yasser A Kamal, MD principal investigator
Minia University
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Tricuspid Regurgitation, run by Minia University.
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 5 inclusion and 8 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Residual tricuspid regirgitation (TR) (time frame: 3-33 months). 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 6 Sep 2019.