Clinical Trials Logo
  1. Home
  2. Mitral Valve Replacement
  3. NCT02097420

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

Mitral Valve Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02097420
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date May 7, 2015
Completion date July 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT03283722 - PRESERVE-MITRAL Post-Market Registry
Not yet recruiting NCT06167213 - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral N/A
Recruiting NCT06001489 - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy N/A
Recruiting NCT06025149 - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed NCT05193760 - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Completed NCT05836558 - Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term?
Recruiting NCT05531253 - Respired Gases in Patients Post Cardiac Surgery
Completed NCT04045340 - Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Recruiting NCT02925819 - Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
Completed NCT03438825 - PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Recruiting NCT03574311 - Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery Phase 4
Recruiting NCT06153563 - Evaluation of the Elasticity of the Mitral Valve
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Recruiting NCT05898230 - Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Withdrawn NCT01849757 - Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5% N/A
Active, not recruiting NCT04147884 - A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation N/A
Enrolling by invitation NCT04067635 - Primary Mitral Regurgitation Repair
Recruiting NCT04954404 - Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M) N/A