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

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ClinicalTrials.gov Identifier: NCT03278418
Recruitment Status : Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation

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.

Condition or disease Intervention/treatment Phase
Tricuspid Valve Insufficiency Procedure: Tricuspid Valve Repair Procedure: Left-sided valve surgery Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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)

  6. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278418


Contacts
Contact: Mauro Del Giglio, MD +390545217445 mdelgiglio@gvmnet.it
Contact: Donato Mele, MD +393476411190 donatomele@libero.it

Locations
Italy
Maria Cecilia Hospital Active, not recruiting
Cotignola, Ravenna, Italy, 48033
IRCCS Policlinico San Donato Not yet recruiting
Milano, Italy, 20097
Contact: Alessandro Frigiola, MD, PhD    +390252774392    alessandro.frigiola@grupposandonato.it   
IRCCS Opsedale San Raffaele Not yet recruiting
Milano, Italy, 20132
Contact: Ottavio Alfieri, MD, PhD    +390226437102    cardiochirurgia@hsr.it   
Maria Eleonora Hospital Not yet recruiting
Palermo, Italy, 90135
Contact: Khalil Fattouch, MD, PhD    +393288105584    khalilfattouch@hotmail.com   
Sponsors and Collaborators
Ettore Sansavini Health Science Foundation
Investigators
Study Director: Maria Salomone, MD Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS

Responsible Party: Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier: NCT03278418     History of Changes
Other Study ID Numbers: ESREFO 32
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases