Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach (RIGHT)

September 7, 2017 updated by: Ettore Sansavini Health Science Foundation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20097
        • IRCCS Policlinico San Donato
      • Milano, Italy, 20132
        • IRCCS Opsedale San Raffaele
      • Palermo, Italy, 90135
        • Maria Eleonora Hospital
    • Ravenna
      • Cotignola, Ravenna, Italy, 48033
        • Maria Cecilia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tricuspid Valve Repair
Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery
Procedure: Tricuspid Valve Repair
It will be performed according to the surgeon preference
Procedure: Left-sided valve surgery
It will be performed according to the surgeon preference
ACTIVE_COMPARATOR: left-sided valve surgery
No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery
Procedure: Left-sided valve surgery
It will be performed according to the surgeon preference

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Significant TR (moderate or severe)
Time Frame: 1 and 2 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).
1 and 2 years
Mild TR
Time Frame: 1,2 and 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 non severe (≤10 cm2) or mild (<5 cm2).
1,2 and 3 years
Overall TR (mild, moderate, severe)
Time Frame: 1, 2 and 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 non severe (≤10 cm2; mild <5 cm2, moderate = 5-10 cm2), or severe (>10 cm2).
1, 2 and 3 years
RV function
Time Frame: 1, 2 and 3 years
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.
1, 2 and 3 years
Pulmonary Artery Pressure (PAP)
Time Frame: 1, 2 and 3 years
To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)
1, 2 and 3 years
Event free survival
Time Frame: 3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ettore Sansavini Health Science Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESREFO 32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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