Key result
The HOVER trial is a prospective, non-randomized study designed to evaluate the safety and feasibility of caval valve implantation for severe tricuspid regurgitation in 30 high-risk patients.
Why the study?
Does heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava provide procedural and patient success in high-risk or inoperable patients with severe tricuspid regurgitation?
Does heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava provide procedural and patient success in high-risk or inoperable patients with severe tricuspid regurgitation?
The HOVER trial is designed to evaluate the safety and feasibility of heterotopic caval valve implantation as an alternative for high-risk or inoperable patients with severe tricuspid regurgitation.
Initial feasibility data support further study of caval valve implantation; leaves open randomized efficacy trials in severe tricuspid regurgitation.
BACKGROUND: Tricuspid regurgitation (TR) is an under treated disease. Although surgery for TR remains an effective therapy, many patients are considered to be at a high risk or otherwise inoperable. Caval valve implant (CAVI) offers an alternative to surgery in these patients. Trials assessing the safety and efficacy of caval valve implant are lacking. METHODS: The Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna cava for the treatment of severe Tricuspid Regurgitation (HOVER) trial is an FDA approved, physician initiated, prospective, non-blinded (open label), non-randomized safety and feasibility study to determine the safety and efficacy of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe TR in patients who are at high risk or inoperable. Patients with severe TR in the absence of severe pulmonary hypertension will be recruited. They will be evaluated by a multi-disciplinary team who will agree by consensus that the patients' symptoms are from TR. They will undergo imaging to assess the size of the inferior vena cava (IVC) to determine feasibility of the procedure. If patients meet the inclusion criteria and are free from exclusion criteria, after informed consent they will be eligible for enrollment in the study. A total of 30 patients will be enrolled. The primary objective of the study will be to demonstrate procedural success at 30-days and patient success at 1-year. CONCLUSION: Caval valve implant may present an alternative for patients who are at high risk or inoperable for tricuspid valve surgery (TVS) for TR.
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O’Neill et al. (2016) studied severe tricuspid regurgitation (n=30). Heterotopic implantation of the Edwards-Sapien XT transcatheter valve in the inferior vena cava was evaluated on procedural success at 30-days and patient success at 1-year. The HOVER trial is a prospective, non-randomized study designed to evaluate the safety and feasibility of caval valve implantation for severe tricuspid regurgitation in 30 high-risk patients.
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