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.
Abbott Structural Heart Device Registry
At a glance
Conditions
Where it's being run
28 sites across 23 statesStudy leadership
- Mary Seale · STUDY_DIRECTOR · Abbott
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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