Clinical trial NCT03278418: Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
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
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Significant TR (moderate or severe)
timeFrame: 3 years
Secondary outcomes:
measure: Significant TR (moderate or severe)
timeFrame: 1 and 2 years
measure: Mild TR
timeFrame: 1,2 and 3 years
measure: Overall TR (mild, moderate, severe)
timeFrame: 1, 2 and 3 years
measure: RV function
timeFrame: 1, 2 and 3 years
measure: Pulmonary Artery Pressure (PAP)
timeFrame: 1, 2 and 3 years
measure: Event free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Milano
country: Italy
facility: IRCCS Policlinico San Donato
city: Milano
country: Italy
facility: IRCCS Opsedale San Raffaele
city: Palermo
country: Italy
facility: Maria Eleonora Hospital
Study officials:
affiliation: Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
name: Maria Salomone, MD
role: STUDY_DIRECTOR
References: