StudyFinder
Clinical Safety and Performance of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation - VISTA-US
Status: Recruiting
This study assesses the VDyne Transcatheter Tricuspid Valve Replacement System's safety and efficacy in treating severe tricuspid regurgitation. Participants receive the VDyne System, with outcomes measured within 30 days and monitored up to 1 year, including adverse events, changes in valve regurgitation, symptom status, and quality of life.
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
Age >18 years.
Symptomatic severe tricuspid regurgitation (TR).
Must be able to walk.
Adequately treated with heart failure therapy, including a diuretic.
Heart Team recommendation for VDyne System.
Exclusion Criteria:
Prior tricuspid valve surgery or therapy.
Significant other valvular disease requiring intervention.
Stroke within 6 months.
Severe COPD or continuous use of home oxygen or oral steroids.
On dialysis.Interventions:
Drug/Device: VDyne
Conditions:
Adults with severe mitral regurgitation
Keywords:
Patients with severe tricuspid regurgitation
Contact(s): Sahar Razmjou - srazmjo1@hfhs.org
Principal Investigator: Brian O'Neill
Principal Investigator ID: boneil3@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov