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

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: Unknown
• Conditions: Tricuspid Valve Insufficiency
• Intervention / Treatment: Procedure: Tricuspid Valve Repair; Procedure: Left-sided valve surgery

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: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauro Del Giglio, MD; Phone Number: +390545217445; Email: mdelgiglio@gvmnet.it
• Study Contact Backup: Name: Donato Mele, MD; Phone Number: +393476411190; Email: donatomele@libero.it

Study Locations

• Italy
  • Milano, Italy, 20097
    • IRCCS Policlinico San Donato
    • Contact: Alessandro Frigiola, MD, PhD; Phone Number: +390252774392; Email: alessandro.frigiola@grupposandonato.it
  • Milano, Italy, 20132
    • IRCCS Opsedale San Raffaele
    • Contact: Ottavio Alfieri, MD, PhD; Phone Number: +390226437102; Email: cardiochirurgia@hsr.it
  • Palermo, Italy, 90135
    • Maria Eleonora Hospital
    • Contact: Khalil Fattouch, MD, PhD; Phone Number: +393288105584; Email: khalilfattouch@hotmail.com
  • Ravenna
    • Cotignola, Ravenna, Italy, 48033
      • Maria Cecilia Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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)	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	3 years

Collaborators and Investigators

• Sponsor: Ettore Sansavini Health Science Foundation

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (ACTUAL): September 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID 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