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

Ettore Sansavini Health Science Foundation

Status: Unknown

Conditions: Tricuspid Valve Insufficiency

Treatments: Procedure: Tricuspid Valve Repair; Procedure: Left-sided valve surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03278418

ESREFO 32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Tricuspid Valve Repair

Experimental group

Description:

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

Treatment:

Procedure: Tricuspid Valve Repair

Procedure: Left-sided valve surgery

left-sided valve surgery

Active Comparator group

Description:

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

Treatment:

Procedure: Left-sided valve surgery