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ClinicalTrials.gov ID

NCT03278418

Lead Sponsor

Ettore Sansavini Health Science FoundationOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

280Estimated

Last Update Posted

Sep 11, 2017Actual

Start Date

Sep 2017Estimated

Primary Completion Date

Sep 2021Estimated

Completion Date

Oct 2021Estimated

Official Title

Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study

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.

• Tricuspid Valve Insufficiency

• Tricuspid Valve Repair
• Left-sided valve surgery

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Ettore Sansavini Health Science FoundationOTHER

cardiochirurgia@hsr.it+390226437102

khalilfattouch@hotmail.com+393288105584