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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 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.

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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.

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

FieldValue
Enrollment Target 2,500 participants
Start Date 2024-08-21
Est. Completion 2039-11

Sponsor

Abbott Medical Devices

261 total trials

What the Registry Record Tells You About NCT06590467

The ClinicalTrials.gov registry entry for NCT06590467 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,503-participant average among 85 other Heart Diseases trials with a reported enrollment target (55% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.