HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Public ClinicalTrials.gov record NCT02097420. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Study identification
- NCT ID
- NCT02097420
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Abbott Medical Devices
- Industry
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Interventions
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve Device
Device
Eligibility (public fields only)
- Age range
- Up to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 6, 2015
- Primary completion
- Feb 28, 2019
- Completion
- Jun 30, 2023
- Last update posted
- Feb 10, 2025
2015 – 2023
United States locations
- U.S. sites
- 24
- U.S. states
- 21
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Children's Hospital Los Angeles (USC) | Los Angeles | California | 90027 | — |
| University of California - Davis Medical Center | Sacramento | California | 95817 | — |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | — |
| University of Missouri-Kansas City School of Medicine | Kansas City | Missouri | 62108 | — |
| Children's Hospital & Medical Center | Omaha | Nebraska | 68198 | — |
| New York Presbyterian Hospital/Columbia University | New York | New York | 10032 | — |
| Levine Children's Hospital / Sanger Heart & Vascular Institute | Charlotte | North Carolina | 28203 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84113 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02097420, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2025 · Synced Jun 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02097420 live on ClinicalTrials.gov.