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

Primary Purpose

Tricuspid Valve Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tricuspid Valve Repair
Left-sided valve surgery
Sponsored by
Ettore Sansavini Health Science Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Valve Insufficiency

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maria Cecilia Hospital
  • IRCCS Policlinico San Donato
  • IRCCS Opsedale San Raffaele
  • Maria Eleonora Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tricuspid Valve Repair

left-sided valve surgery

Arm Description

Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery

No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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.
Pulmonary Artery Pressure (PAP)
To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)
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

Full Information

First Posted
August 31, 2017
Last Updated
September 7, 2017
Sponsor
Ettore Sansavini Health Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03278418
Brief Title
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
Acronym
RIGHT
Official Title
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ettore Sansavini Health Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tricuspid Valve Repair
Arm Type
Experimental
Arm Description
Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery
Arm Title
left-sided valve surgery
Arm Type
Active Comparator
Arm Description
No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery
Intervention Type
Procedure
Intervention Name(s)
Tricuspid Valve Repair
Intervention Description
It will be performed according to the surgeon preference
Intervention Type
Procedure
Intervention Name(s)
Left-sided valve surgery
Intervention Description
It will be performed according to the surgeon preference
Primary Outcome Measure Information:
Title
Significant TR (moderate or severe)
Description
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).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Significant TR (moderate or severe)
Description
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).
Time Frame
1 and 2 years
Title
Mild TR
Description
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).
Time Frame
1,2 and 3 years
Title
Overall TR (mild, moderate, severe)
Description
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).
Time Frame
1, 2 and 3 years
Title
RV function
Description
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.
Time Frame
1, 2 and 3 years
Title
Pulmonary Artery Pressure (PAP)
Description
To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)
Time Frame
1, 2 and 3 years
Title
Event free survival
Description
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
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro Del Giglio, MD
Phone
+390545217445
Email
mdelgiglio@gvmnet.it
First Name & Middle Initial & Last Name or Official Title & Degree
Donato Mele, MD
Phone
+393476411190
Email
donatomele@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Salomone, MD
Organizational Affiliation
Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
Official's Role
Study Director
Facility Information:
Facility Name
Maria Cecilia Hospital
City
Cotignola
State/Province
Ravenna
ZIP/Postal Code
48033
Country
Italy
Facility Name
IRCCS Policlinico San Donato
City
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Frigiola, MD, PhD
Phone
+390252774392
Email
alessandro.frigiola@grupposandonato.it
Facility Name
IRCCS Opsedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ottavio Alfieri, MD, PhD
Phone
+390226437102
Email
cardiochirurgia@hsr.it
Facility Name
Maria Eleonora Hospital
City
Palermo
ZIP/Postal Code
90135
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalil Fattouch, MD, PhD
Phone
+393288105584
Email
khalilfattouch@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach

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