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NCT06590467 · ClinicalTrials.gov registry record
Abbott Structural Heart Device Registry
A clinical trial of Heart Diseases and Valvular Heart Disease, sponsored by Abbott Medical Devices.
- Recruiting
- Registry status
- 2,500
- Enrollment target
- 20
- Study locations
NCT06590467: Recruiting study of Heart Diseases and Valvular Heart Disease, sponsored by Abbott Medical Devices.
NCT06590467 is a study of Heart Diseases and Valvular Heart Disease that is actively recruiting participants, run by Abbott Medical Devices. The registered enrollment target is 2,500 participants, below the 5,503-participant average among 85 other Heart Diseases trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06590467, a study of Heart Diseases and Valvular Heart Disease, is actively recruiting participants, sponsored by Abbott Medical Devices.
- RECRUITING
- Registry status
- 2,500 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The primary safety endpoint will be the proportion of subjects with device- and/or procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure.
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 |
What NCT06590467 shows while recruiting
NCT06590467 is an observational study that tracks outcomes without assigning an intervention. Its 2,500 participants enrollment target places it among the larger protocols in the corpus, below the 5,503-participant average among 85 other Heart Diseases trials with a reported enrollment target (55% lower).
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.
NCT06590467 names 20 study sites across 17 states, led by Other, Lombardy, New Jersey.
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.
What interventions are being tested in trial NCT06590467?
The interventions under investigation include: Amplatzer™ Occlusion Devices (DEVICE), Epic™ Surgical Tissue Heart Valve devices (DEVICE).
Who is sponsoring clinical trial NCT06590467?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06590467's enrollment target sits among peer trials
2,500 15th of 85 higher than 71 of 85 other Heart Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Diseases 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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