Abbott Structural Heart Device Registry

This registry is observing how Abbott's heart devices, like the Amplatzer™ Occlusion Devices (used to close holes in the heart) and Epic™ Surgical Tissue Heart Valve devices (used to replace heart valves), perform in real-world settings. It's for people who are expected to receive or have recently received one of these devices for conditions like Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), or Patent Foramen Ovale (PFO). The study aims to confirm the safety and effectiveness of these devices by collecting information from your routine hospital visits and procedures. The goal is to gather data to meet regulatory requirements.

Study design
This is an observational study, meaning researchers will collect information from your routine care. It plans to enroll about 2500 participants over at least 5 years.
What's involved
You would need to be willing to follow your usual hospital follow-up schedule. Data will be collected after you agree to participate and at your standard follow-up appointments.
Compensation
Not stated in the trial record.
Follow-up
The length of follow-up depends on which Abbott device you receive. Data collection will occur at post-procedure standard-of-care follow-up visits.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06590467

Abbott Structural Heart Device Registry

Recruiting
Not specifiedAll AgesObservational
Abbott Medical Devices
~2,500 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Amplatzer™ Occlusion DevicesEpic™ Surgical Tissue Heart Valve devices

At a glance

Recruiting sites
27 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint
Measured over 7 days
+1 more outcome measured
Heart Diseases
ASD - Atrial Septal Defect
VSD - Muscular Ventricular Septal Defect
PFO - Patent Foramen Ovale
PIVSD - Post Infarct Muscular Ventricular Septal Defect
Valvular Heart Disease
28 sites across 23 states
Pennsylvania2
France2
Germany2
Lombardy2
Spain2
New Jersey1
New York1
Virginia1
  • Mary Seale · STUDY_DIRECTOR · Abbott

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  • Primary Safety Endpoint7 days

    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.

  • Primary Effectiveness EndpointBaseline

    The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted