Tricuspid (Valve) Insufficiency (Rheumatic)PROCIDANCT03129737
PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus
A study testing Mitral valve surgery and Tricuspid valve annuloplasty in people with Tricuspid (Valve) Insufficiency (Rheumatic), run by Ettore Sansavini Health Science Foundation at 8 sites in Italy.
Trial summary
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid (Valve) Insufficiency (Rheumatic)
- What is being tested?
- Mitral valve surgery and Tricuspid valve annuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesItaly
- Study dates
- 17 May 2017to Jun 2020
- 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
- Patients undergoing mitral valve surgery (either repair or replacement) with less/equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2 BSA) at preoperative echocardiography and fulfilling the following selection criteria:
- Written informed consent
- Degenerative mitral valve disease
- > 18 years old
Who cannot join
- Main exclusion criteria:
- Presence of structural or organic tricuspid valve disease
- urgent operation
- presence of pacemaker leads through the tricuspid annulus
- acute endocarditis or other organic valve diseases
- previous surgical procedure
Show all 10Show fewer
- Severe TR
- Associated cardiac procedure
- NYHA class IV
- Severe COPD (GOLD class 3,4)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 7 recruiting
- Not yet recruiting
Anthea Hospital
Bari, 70124
Giuseppe Speziale, MD,PhD
gspeziale@gvmnet.it
- Not yet recruiting
Ospedale Santa Maria
Bari, 70124
Domenico Paparella, MD, PhD
domenico.paparella@uniba.it
- Recruiting
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
Mauro Del Giglio, MD
mdelgiglio@gvmnet.it
- Recruiting
Città di Lecce Hospital
Lecce, 73100
Renato Gregorini, MD
re.greg@tin.it
- Not yet recruiting
Casa di Cura Montevergine
Mercogliano, Avellino, 83013
Carlo Zebele, MD
carlo.zebele@gmail.com
- Active, not recruiting
Maria Eleonora Hospital
Palermo, 90135
- Not yet recruiting
ICLAS
Rapallo, Genova, 16035
Luigi Martinelli, MD
lumartinelli49@virgilio.it
- Not yet recruiting
Maria Pia Hospital
Torino, 10132
Chiara Comoglio, MD
chiaracomoglio@gmail.com
About this study
Official title: Multi-centre Randomised Trial Investigating the Effect of PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus on Tricuspid Regurgitation Progression, Right Ventricular Remodeling and Functional Outcomes
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty 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 20 to 40 patients over a 12-month enrolment period.
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.
After discharge patients will be assessed at 1 month (phone contact), 6 month and 1-year after surgery.
- Being tested
- Mitral valve surgery, Tricuspid valve annuloplasty
- 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.
Mitral valve surgeryProcedure or surgery
Mitral valve repair is preferred whenever technically feasible over valve replacement. Annuloplasty may be used as sole therapy or in conjunction with other repair maneuvers to support the reconstruction and reinforce the annulus as well as prevent future annular dilatation. The mitral regurgitation secondary to myxomatous degeneration is prolapse of the middle scallop of the posterior leaflet result from chordal rupture or chordal elongation. Quadrangular resection of the involved middle scallop of the posterior leaflet combined with a posterior mitral annuloplasty is the best way to handle this situation. Chordae replacement could be used also to treat flail/prolapse of the anterior leaflet. Annuloplasty is always doing in mitral valve repair to stabilize and reshape the annulus.
Tricuspid valve annuloplastyProcedure or surgery
Depending on the extent of the valve disease, there is the possibility to perform valve repair. In mitral valve reference center the rate of repair will reach 100%. In many patients with mitral valve regurgitation, tricuspid valve will be insufficient or the annulus dilated. Tricuspid annuloplasty ring will be helpful to treat dilation by reshaping, or to treat the regurgitant diseases. The ring will be secured and sutured to the native annulus by U-stitches.
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid valve annuloplasty | Experimental | Concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (>21mm /m2) with or without TR≤ moderate in pts undergoing mitral valve surgery Receives: Procedure: Mitral valve surgery; Procedure: Tricuspid valve annuloplasty |
| Mitral valve repair | Active comparator | No concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (>21mm/m2) with or without TR ≤ moderate in pts undergoing mitral valve surgery Receives: Procedure: Mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of TR
Progression of TR at one year follow-up defined as worsening of at least one class with respect to pre-surgery as assessed by the Core lab evaluation of the echocardiogram.
Measured: 1 year
Secondary outcomes (2)
Evaluation of reverse right ventricle (RV) remodelling
The evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters with respect to pre-surgery
Measured: 1 year
Residual TR
Percentage of patients with moderate to severe TR at one year after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start17 May 2017
- Primary completionFeb 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid (Valve) Insufficiency (Rheumatic)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT03129737
- Sponsor's protocol ID
- ESREFO 18
- Acronym
- PROCIDA
- Status last verified
- Jun 2017
- First submitted
- 18 Apr 2017
- Last updated
- 28 Jun 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 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Randomised Trial Investigating the Effect of PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus on Tricuspid Regurgitation Progression, Right Ventricular Remodeling and Functional Outcomes
- ClinicalTrials.gov ID
- NCT03129737
- Acronym / sponsor ID
- PROCIDA / ESREFO 18
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ettore Sansavini Health Science FoundationUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 26 Apr 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 mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty 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 20 to 40 patients over a 12-month enrolment period.
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.
After discharge patients will be assessed at 1 month (phone contact), 6 month and 1-year after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tricuspid valve annuloplasty | Experimental | Procedure: Mitral valve surgery, Procedure: Tricuspid valve annuloplastyConcomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (>21mm /m2) with or without TR≤ moderate in pts undergoing mitral valve surgery |
| Mitral valve repair | Active comparator | Procedure: Mitral valve surgeryNo concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (>21mm/m2) with or without TR ≤ moderate in pts undergoing mitral valve surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing mitral valve surgery (either repair or replacement) with less/equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2 BSA) at preoperative echocardiography and fulfilling the following selection criteria:
- Written informed consent
- Degenerative mitral valve disease
- > 18 years old
Key exclusion criteria (10 listed)
- Presence of structural or organic tricuspid valve disease
- urgent operation
- presence of pacemaker leads through the tricuspid annulus
- acute endocarditis or other organic valve diseases
- previous surgical 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 |
|---|---|---|
| Mitral valve surgeryMitral valve repair is preferred whenever technically feasible over valve replacement. Annuloplasty may be used as sole therapy or in conjunction with other repair maneuvers to support the reconstruction and reinforce the annulus as well as prevent future annular dilatation. The mitral regurgitation secondary to myxomatous degeneration is prolapse of the middle scallop of the posterior leaflet result from chordal rupture or chordal elongation. Quadrangular resection of the involved middle scallop of the posterior leaflet combined with a posterior mitral annuloplasty is the best way to handle this situation. Chordae replacement could be used also to treat flail/prolapse of the anterior leaflet. Annuloplasty is always doing in mitral valve repair to stabilize and reshape the annulus. | Procedure or surgery | Mitral valve repair, Tricuspid valve annuloplasty |
| Tricuspid valve annuloplastyDepending on the extent of the valve disease, there is the possibility to perform valve repair. In mitral valve reference center the rate of repair will reach 100%. In many patients with mitral valve regurgitation, tricuspid valve will be insufficient or the annulus dilated. Tricuspid annuloplasty ring will be helpful to treat dilation by reshaping, or to treat the regurgitant diseases. The ring will be secured and sutured to the native annulus by U-stitches. | Procedure or surgery | Tricuspid valve annuloplasty |
Primary outcome
Progression of TR
Time frame: 1 year
Progression of TR at one year follow-up defined as worsening of at least one class with respect to pre-surgery as assessed by the Core lab evaluation of the echocardiogram.
2 secondary outcomes
Evaluation of reverse right ventricle (RV) remodelling
Time frame: 1 year
Residual TR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Tricuspid (Valve) Insufficiency (Rheumatic)
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Heart Valve Diseases, Aortic Valve Stenosis
RecruitingObservational study
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Cardiac Pacing, Artificial, Tricuspid Valve Regurgitation, Non-rheumatic
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral valve surgery and Tricuspid valve annuloplasty in people with Tricuspid (Valve) Insufficiency (Rheumatic), run by Ettore Sansavini Health Science Foundation at 8 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 10 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 Khalil Fattouch, MD (+39 328 8105584, khalilfattouch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of TR (time frame: 1 year). 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 28 Jun 2017.