Tricuspid Valve InsufficiencyRIGHTNCT03278418
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
A study testing Tricuspid Valve Repair and Left-sided valve surgery in people with Tricuspid Valve Insufficiency, run by Ettore Sansavini Health Science Foundation at 4 sites in Italy.
Trial summary
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- Tricuspid Valve Repair and Left-sided valve surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 4 sitesItaly
- Study dates
- Sep 2017to Oct 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing left-sided valve surgery for left-sided valve disease
- Presence of non-severe TR and tricuspid annular dilation (>40 mm or > 21 mm/m2 BSA) determined by echocardiography
- Age ≥ 18 years
- Capability to sign Informed Consent and Release of Medical Information forms
Who cannot join
- Preoperative severe TR
- Structural / organic tricuspid valve disease
- Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE
- Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV
- Any type of reoperative surgery
- Concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery)
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- Cardiogenic shock at the time of randomization
- ST-elevated myocardial infarction requiring intervention within 7 days prior to randomization
- Evidence of cirrhosis or hepatic synthetic failure
- Severe, irreversible pulmonary hypertension in the judgment of the investigator
- Pregnancy at the time of randomization
- Any concurrent disease with life expectancy < 1 year
- Patient unable or unwilling to provide informed consent
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
IRCCS Policlinico San Donato
Milan, 20097
Alessandro Frigiola, MD, PhD, +390252774392, alessandro.frigiola@grupposandonato.it
IRCCS Opsedale San Raffaele
Milan, 20132
Ottavio Alfieri, MD, PhD, +390226437102, cardiochirurgia@hsr.it
Maria Eleonora Hospital
Palermo, 90135
Khalil Fattouch, MD, PhD, +393288105584, khalilfattouch@hotmail.com
About this study
Official title: Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.
Read the detailed description
The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 70 patients over a 12 months enrolment period.
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.
After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- Tricuspid Valve Repair, Left-sided valve 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
It will be performed according to the surgeon preference
Left-sided valve surgeryProcedure or surgery
It will be performed according to the surgeon preference
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid Valve Repair | Experimental | Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery Receives: Procedure: Tricuspid Valve Repair; Procedure: Left-sided valve surgery |
| left-sided valve surgery | Active comparator | No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery Receives: Procedure: Left-sided valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant TR (moderate or severe)
To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2).
Measured: 3 years
Secondary outcomes (6)
Significant TR (moderate or severe)
To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2).
Measured: 1 and 2 years
Mild TR
To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2) or mild (<5 cm2).
Measured: 1,2 and 3 years
Overall TR (mild, moderate, severe)
To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2; mild <5 cm2, moderate = 5-10 cm2), or severe (>10 cm2).
Measured: 1, 2 and 3 years
RV function
To compare the effect of the 2 strategies for non-severe TR described above on the evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters.
Measured: 1, 2 and 3 years
Pulmonary Artery Pressure (PAP)
To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)
Measured: 1, 2 and 3 years
Event free survival
Safety evaluation will rely on all AE/SAEs subsequent to spontaneous reporting, or to detection of clinically relevant abnormalities on physical examinations, vital signs, ECG, and laboratory tests
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ettore Sansavini Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Salomone, MD, Study director, Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278418
- Sponsor's protocol ID
- ESREFO 32
- Acronym
- RIGHT
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03278418
- Acronym / sponsor ID
- RIGHT / ESREFO 32
- Conditions
- Tricuspid Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ettore Sansavini Health Science FoundationUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 11 Sep 2017 (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.
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.
Detailed description
The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 70 patients over a 12 months enrolment period.
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.
After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tricuspid Valve Repair | Experimental | Procedure: Tricuspid Valve Repair, Procedure: Left-sided valve surgeryConcomitant tricuspid valve repair in patients undergoing left-sided valve surgery |
| left-sided valve surgery | Active comparator | Procedure: Left-sided valve surgeryNo concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing left-sided valve surgery for left-sided valve disease
- Presence of non-severe TR and tricuspid annular dilation (>40 mm or > 21 mm/m2 BSA) determined by echocardiography
- Age ≥ 18 years
- Capability to sign Informed Consent and Release of Medical Information forms
Key exclusion criteria (13 listed)
- Preoperative severe TR
- Structural / organic tricuspid valve disease
- Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE
- Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV
- Any type of reoperative surgery
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 RepairIt will be performed according to the surgeon preference | Procedure or surgery | Tricuspid Valve Repair |
| Left-sided valve surgeryIt will be performed according to the surgeon preference | Procedure or surgery | Tricuspid Valve Repair, left-sided valve surgery |
Primary outcome
Significant TR (moderate or severe)
Time frame: 3 years
To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2).
6 secondary outcomes
Significant TR (moderate or severe)
Time frame: 1 and 2 years
Mild TR
Time frame: 1,2 and 3 years
Overall TR (mild, moderate, severe)
Time frame: 1, 2 and 3 years
RV function
Time frame: 1, 2 and 3 years
Pulmonary Artery Pressure (PAP)
Time frame: 1, 2 and 3 years
Event free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
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The TRICURE US IDE Pivotal Study
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EFS of the DUO System for Tricuspid Regurgitation
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Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
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.
Maria Salomone, MD study director
Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
4 sites 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 Left-sided valve surgery in people with Tricuspid Valve Insufficiency, run by Ettore Sansavini Health Science Foundation at 4 sites in Italy.
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 13 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: status not confirmed, as of the sponsor's last update on 11 Sep 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro Del Giglio, MD (+390545217445, mdelgiglio@gvmnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant TR (moderate or severe) (time frame: 3 years). 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 11 Sep 2017.