Abbott Structural Heart Device Registry

Recruiting

• Conditions: 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
• Interventions: Device: Amplatzer™ Occlusion Devices; Device: Epic™ Surgical Tissue Heart Valve devices

• Registration Number: NCT06590467
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

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:

* Amplatzer portion: within 7 days post-procedure

* Cardiac Surgery portion: within 6 months post-procedure.

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).

Study Timeline

• Study Start: 2024-08-21
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2029-07
• Study Completion: 2039-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
2. Subject is willing and able to comply with the site's standard of care follow-up schedule.
3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.

Exclusion Criteria

1. Subject is participating in another clinical study that would affect the results of this Registry.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amplatzer	Amplatzer™ Occlusion Devices	* 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 * SB II:100 PFO cases/year \& 100 ASD cases/year * GW: 200 cases/year
Cardiac Surgery	Epic™ Surgical Tissue Heart Valve devices	It is anticipated that approximately 830 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years. * Approximately 225 subjects receiving Epic Plus mitral valves * Approximately 150 subjects receiving Epic Plus aortic valves * Approximately 170 subjects receiving Epic Plus Supra aortic valves * Approximately 285 subjects receiving Epic Max aortic valves

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	7 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 Endpoint	Baseline	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

Trial Locations

Locations (10)

Policlinico San Donato; 🇮🇹 San Donato Milanese, Lombardy, Italy

Centre Médico Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

Deutsches Herzzentrum München des Freistaates Bayern; 🇩🇪 Munchen, Bavaria, Germany

Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG; 🇩🇪 Bad Rothenfelde, Germany

Universitatsklinikum Jena; 🇩🇪 Jena, Germany

Hospital Universitario de la Paz - Pediatrico; 🇪🇸 Madrid, Spain

Hospital Virgen de Rocio; 🇪🇸 Sevilla, Spain

Royal Brompton Hospital; 🇬🇧 London, UK, United Kingdom

St. Thomas Hospital; 🇬🇧 London, United Kingdom