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Abbott Structural Heart Device Registry
NCT06590467 · View on ClinicalTrials.gov ↗
Study Summary
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
Conditions Studied
Interventions
- DEVICE Amplatzer™ Occlusion Devices
- DEVICE Epic™ Surgical Tissue Heart Valve devices
Study Locations (20)
Other
- Centre Médico Chirurgical Marie Lannelongue — Le Plessis-Robinson
- Hopital Haut Leveque — Pessac
- Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG — Bad Rothenfelde
Lombardy
- IRCCS Policlinico San Donato - Cardio — San Donato Milanese
- Policlinico San Donato — San Donato Milanese
New Jersey
- Robert Wood Johnson University Hospital — New Brunswick
New York
- Mount Sinai Hospital — New York
Pennsylvania
- UPMC — Pittsburgh
Virginia
- Sentara Norfolk General Hospital — Norfolk
Southern Denmark
- Odense University Hospital — Odense
Tartu
- Tartu University Hospital — Tartu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2024-08-21 |
| Est. Completion | 2039-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06590467
The ClinicalTrials.gov registry entry for NCT06590467 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Heart Diseases appearing as the primary indexed condition, and to 2 interventions — of which Amplatzer™ Occlusion Devices is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06590467 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Other, Lombardy, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06590467 about?
NCT06590467 is a clinical study titled "Abbott Structural Heart Device Registry". The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patient...
What is the current status of trial NCT06590467?
This trial is currently recruiting. The enrollment target is 2,500 participants. The study started on 2024-08-21. Estimated completion is 2039-11.
What conditions does trial NCT06590467 study?
This clinical trial studies the following conditions: Heart Diseases, Valvular Heart Disease, PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06590467?
The interventions under investigation include: Amplatzer™ Occlusion Devices (DEVICE), Epic™ Surgical Tissue Heart Valve devices (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06590467?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06590467 being conducted?
This trial has 20 study locations across New Jersey, New York, Pennsylvania, Virginia, Southern Denmark. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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