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NCT03924661 · ClinicalTrials.gov registry record
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
A clinical trial of Aortic Valve Disease, sponsored by Abbott Medical Devices.
- Active
- Registry status
- 20
- Enrollment target
- 13
- Study locations
NCT03924661: Active study of Aortic Valve Disease, sponsored by Abbott Medical Devices.
NCT03924661 is a study of Aortic Valve Disease that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 20 participants, below the 18,616-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03924661, a study of Aortic Valve Disease, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 13
- Study locations
Study Summary
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.
Primary Outcome
actuarial (Kaplan-Meier) rate of total serious valve-related adverse events experienced through 5 years post implant or until the valve is removed/replaced. Valve-related adverse events to be evaluated are: * Death; * Endocarditis; * Hemorrhage (whether or not due to anticoagulant/antiplatelet medication); * Nonstructural dysfunction (including perivalvular leak, hemolysis, and hemolytic anemia); * Reoperation (including valve explant, not due to anatomical growth of the subject); * Structural
Conditions Studied
Interventions
- DEVICE Aortic Valve Replacement
Study Locations (13)
California
- Children's Hospital Los Angeles (USC) - Los Angeles
- Valley Children's Hospital - Madera
- Sutter Medical Center, Sacramento - Sacramento
Texas
- Dell Children's Medical Center - Austin
- Children's Medical Center Dallas - Dallas
Florida
- Variety Children's Hospital - Miami
Georgia
- Children's Healthcare of Atlanta - Atlanta
Mississippi
- University of Mississippi Medical Center - Jackson
Ohio
- Cincinnati Children's Hospital - Cincinnati
Baden-Wurttemberg
- Sana - Herzchirurgische Klinik Stuttgart GmbH - Stuttgart
Bavaria
- Deutsches Herzzentrum München des Freistaates Bayern - München
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-10-24 |
| Est. Completion | 2028-10 |
What the registry record for NCT03924661 still lists
NCT03924661 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 18,616-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which Aortic Valve Replacement is the first listed.
NCT03924661 lists 13 locations in 10 states (California, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT03924661 about?
NCT03924661 is a clinical study titled "SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy". This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, dama...
What is the current status of trial NCT03924661?
This trial is currently active not recruiting. The enrollment target is 20 participants. The study started on 2019-10-24. Estimated completion is 2028-10.
What conditions does trial NCT03924661 study?
This clinical trial studies the following conditions: Aortic Valve Disease.
What interventions are being tested in trial NCT03924661?
The interventions under investigation include: Aortic Valve Replacement (DEVICE).
Who is sponsoring clinical trial NCT03924661?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03924661 being conducted?
This trial has 13 study locations across California, Florida, Georgia, Mississippi, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03924661's enrollment target sits among peer trials
20 15th of 15 the lowest of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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