Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
NCT ID: NCT03278418
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
280 participants
INTERVENTIONAL
2017-09-30
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tricuspid Valve Repair
Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery
Tricuspid Valve Repair
It will be performed according to the surgeon preference
Left-sided valve surgery
It will be performed according to the surgeon preference
left-sided valve surgery
No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery
Left-sided valve surgery
It will be performed according to the surgeon preference
Interventions
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Tricuspid Valve Repair
It will be performed according to the surgeon preference
Left-sided valve surgery
It will be performed according to the surgeon preference
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Ettore Sansavini Health Science Foundation
OTHER
Responsible Party
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Principal Investigators
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Maria Salomone, MD
Role: STUDY_DIRECTOR
Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
Locations
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Maria Cecilia Hospital
Cotignola, Ravenna, Italy
IRCCS Policlinico San Donato
Milan, , Italy
IRCCS Opsedale San Raffaele
Milan, , Italy
Maria Eleonora Hospital
Palermo, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ESREFO 32
Identifier Type: -
Identifier Source: org_study_id
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