NCT04665583

Prehab Prior to Undergoing Tricuspid Intervention

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Tricuspid Valve Disease
• Tricuspid Regurgitation

Interventions

Type	Name	Description
OTHER	Prehabilitation	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.

Timeline

• Start date: 2020-10-25
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2020-12-11
• Last updated: 2022-09-23

Locations

1 site across 1 country: United States