Prehab Prior to Undergoing Tricuspid Intervention

Study Overview
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Brief Summary
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This study will aim to standardize the prehabilitation protocol to optimize patients and document the clinical and echo variables that could improve clinical outcomes of tricuspid valve intervention.

Detailed Description
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Prior to screening activities, each subject will be given an opportunity to ask questions and to understand the details of study participation. Subjects who meet the inclusion and exclusion criteria and have signed an informed consent form will be considered enrolled into the study. After a subject is consented and enrolled in the study, data will be collected prior to any intervention or surgery at the following time points: a) Screening/Baseline b) Day 1 of Prehab c) Day 2 of Prehab d) Day 3 of Prehab e) Day 4 of Prehab, f) and any data collected immediately prior to an intervention or incision (in the case of a surgical patient) Subjects meeting eligibility criteria with planned tricuspid intervention will receive in-hospital optimization with THHBP's Prehab Protocol. Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care. If there are clinical and functional signs of improvement before Day 4, and the subject is ready for TV surgery or any other intervention, they will have Day 4 procedures performed. After the tests and evaluations are completed, the Principal Investigator or Sub-Investigators will decide if the patient is a candidate for TV surgery or another intervention

Official Title
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Single-Center, Prospective, Open-Label Study Standardizing a Prehabilitation Protocol to Optimize Patients Prior to Undergoing Tricuspid Intervention

Conditions
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Tricuspid Valve Disease, Tricuspid Regurgitation

Intervention / Treatment
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* Other: Prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Moderate-Severe or Severe TR Undergoing tricuspid valve surgical or catheter-based intervention Exclusion Criteria: 1. Clinical instability according to the judgement of the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prehabilitation<br>All study patients will receive preoperative optimization with a standardized prehabilitation protocol prior to any intervention. | Other: Prehabilitation<br>* Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in volume status according to daily input/outputs | daily input/outputs (mL) | 4-5 days (Day 1 to Day 4 of Prehab or day of surgical intervention) | 
| Change in volume status according to weight | daily weights (kg) | 5-6 days (Baseline to Day 4 of Prehab or day of surgical intervention) | 
| Change in Severity of Tricuspid Regurgitation by Echocardiographic assessment | severity of tricuspid regurgitation (mild, moderate, severe) | 5 days (Baseline to Day 4 of Prehab) | 
| Change in Nutritional Status | Pre-albumin (mg/dL) | 4 days (Baseline to Day 3 of Prehab) |