An observational study in Heart Diseases, ASD - Atrial Septal Defect and VSD - Muscular Ventricular Septal Defect, sponsored by Abbott Medical Devices. Recruiting at 36 sites in 10 countries. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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.
The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:
All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.
The Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.
Follow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.
The follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices' lifetime.
A surgical valve-specific "Line Extension Sub-Study" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 350 across 592 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure // Cardiac Surgery (The ENDURE Study) cohort: consent within 6 months (183 days) of the implant procedure)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Subject is participating in another clinical study that would affect the results of this Registry.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* ASO: ≥50 cases/year * ASD-MF: ≥50 cases/year * ADO: ≥50 cases/year * ADO II: ≥50 cases/year * Piccolo: ≥50 cases/year * MuVSD: Up to 50 cases/year * PI-VSD: Up to 50 cases/year * Talisman/TDS: ≥100 cases/year * TorqVue Delivery Systems Group 1 (ATV/ITV/EITV/TV2): 250 cases/year across different occluders * TorqVue Delivery Systems Group 2 (TVLP/TVLPC): 100 cases/year across different occluders * Piccolo Delivery System (PDS): 50 cases total * SB II:100 PFO cases/year \& 100 ASD cases/year * GW: 200 cases/year
Device: Amplatzer™ Occlusion Devices
Approximately 1,800 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years. The minimum required sample sizes for each THV model are listed below. Approximately N=100 Epic Max enrollments will occur in the United States. A combined total of approximately N=1000 subjects will be enrolled globally across the Epic Elite (aortic and mitral) and Epic Supra G3 models. * Approximately 225 subjects receiving Epic Plus mitral valves * Approximately 225 subjects receiving Epic Elite mitral valves * Approximately 150 subjects receiving Epic Plus aortic valves * Approximately 170 subjects receiving Epic Plus Supra aortic valves * Approximately 170 subjects receiving Epic Supra G3 aortic valves * Approximately 285 subjects receiving Epic Max aortic valves * Approximately 285 subjects receiving Epic Elite aortic valves
Device: Epic™ Surgical Tissue Heart Valve devices
The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
Also known as: Amplatzer Septal Occluder, Amplatzer Multi-fenestrated (Cribriform) Occluder, Amplatzer Duct Occluder, Amplatzer Piccolo Occluder, Amplatzer Muscular VSD Occluder, Amplatzer Post-Infarct VSD Occluder, Amplatzer Talisman, Amplatzer TorqVue Delivery System, Amplatzer Piccolo Delivery System
The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve.
Also known as: EMAX, E200, ESP200, Sizer Set Model E2000, Sizer Set Model EMAX-1000, Replacement Holder Handles E2000-HA and E2000-HM, Sizer Set Model ESP-1000A, Sizer Set Model EELT-1000A, Sizer Set Model EELT-1000M, Epic Plus Single Sizers Models (Aortic): E2000-19A-S, E2000-21A-S, E2000-23A-S, E2000-25A-S, E2000-27A-S, E2000-29A-S, Epic Plus Single Sizers Models (Mitral): E2000-25M-S, E2000-27M-S, E2000-29M-S, E2000-31M-S, E2000-33M-S, Epic Elite Single Sizers Models (Aortic): EELT-19A-S, EELT-21A-S, EELT-23A-S, EELT-25A-S, EELT-27A-S, EELT-29A-S, EELT, ESP300, Sizer Set Model EF-3000
Primary Safety Endpoint
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.
Time frame: 7 days
Primary Effectiveness Endpoint
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
Time frame: Baseline
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