NCT02097420

HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm. 20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.

Detailed description

The study is a single arm, prospective, non-randomized, multi-center clinical investigation. The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased, damaged, or malfunctioning mitral heart valve. The objective will be evaluated by assessing valve-related adverse events, subject survival, subject growth, and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted.

Conditions

• Mitral Valve Disease
• Damaged Mitral Valve
• Malfunctioning Mitral Heart Valve
• Mitral Valve Replacement

Interventions

Type	Name	Description
DEVICE	Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve	Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions

Timeline

• Start date: 2015-05-07
• Primary completion: 2019-03-01
• Completion: 2023-07-01
• First posted: 2014-03-27
• Last updated: 2025-02-11
• Results posted: 2020-06-02

Locations

24 sites across 1 country: United States