CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valvedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02097420
NCT02097420N/ACompleted
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HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

Abbott Medical Devices·interventional·Posted Mar 27, 2014·Updated Feb 11, 2025

In Brief

A clinical study evaluating Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve for Mitral Valve Disease and 3 related conditions. Completed, enrolled 23 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 27, 2014
Enrollment StartMay 7, 2015
Primary CompletionMar 1, 2019
Study CompletionJul 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.3 years ago

Interventions

Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valvedevice

Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions