Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03278418
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03278418
Study Brief:
Protocol Section:
NCT03278418