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Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach

NCT03278418 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2017-09-11

No results posted yet for this study

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.

Conditions

  • Tricuspid Valve Insufficiency

Interventions

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

Sponsors & Collaborators

  • Ettore Sansavini Health Science Foundation

    lead OTHER

Principal Investigators

  • Maria Salomone, MD · Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2021-09-30
Completion
2021-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278418 on ClinicalTrials.gov