Status:
UNKNOWN
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
Lead Sponsor:
Ettore Sansavini Health Science Foundation
Conditions:
Tricuspid Valve Insufficiency
Eligibility:
All Genders
18-99 years
Phase:
NA
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 pati...
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 te...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03278418
Start Date
September 1 2017
End Date
October 1 2021
Last Update
September 11 2017
Active Locations (4)
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1
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48033
2
IRCCS Policlinico San Donato
Milan, Italy, 20097
3
IRCCS Opsedale San Raffaele
Milan, Italy, 20132
4
Maria Eleonora Hospital
Palermo, Italy, 90135