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NCT02097420 · ClinicalTrials.gov registry record · NA
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT02097420 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 23 participants.
The verdict
NCT02097420, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-05-07 |
| Est. Completion | 2023-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02097420
The ClinicalTrials.gov registry entry for NCT02097420 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve is the first listed.
NCT02097420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02097420 about?
NCT02097420 is a clinical study titled "HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve". 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 enroll...
What is the current status of trial NCT02097420?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2015-05-07. Estimated completion is 2023-07.
What interventions are being tested in trial NCT02097420?
The interventions under investigation include: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve (DEVICE).
Who is sponsoring clinical trial NCT02097420?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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