Abbott Structural Heart Device Registry

Overview

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 (The ENDURE Study): 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).

Interventions

• Device Amplatzer™ Occlusion Devices
  The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
• Device Epic™ Surgical Tissue Heart Valve devices
  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.

Primary outcome measures

• Primary Safety Endpoint [Time frame: 7 days]
• Primary Effectiveness Endpoint [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• 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.
• Subject is willing and able to comply with the site's standard of care follow-up schedule.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 6 centers

• Deutsches Herzzentrum München des Freistaates Bayern — München
• Klinikum Links der Weser — Bremen
• Universitatsklinikum Jena — Jena
• Städt. Klinikum Braunschweig gGmbH — Braunschweig
• Deutsches Herzzentrum der Charité — Berlin
• Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG — Bad Rothenfelde

United States · 5 centers

• Robert Wood Johnson University Hospital — New Brunswick
• Mount Sinai Hospital — New York
• University of Pennsylvania — Philadelphia
• UPMC — Pittsburgh
• Sentara Norfolk General Hospital — Norfolk

Italy · 4 centers

• IRCCS Policlinico San Donato - Cardio — San Donato Milanese
• Policlinico San Donato — San Donato Milanese
• A.O.U. Citta della Salute e della Scienza di Torino — Turin
• Azienda Ospedaliero Universitaria Pisana — Pisa

Spain · 4 centers

• Hospital Infantil Sant Joan De Deu — Esplugues de Llobregat
• Hospital Universitario Central de Asturias — Oviedo
• Hospital Virgen de Rocio — Seville
• Hospital Universitario de la Paz - Pediatrico — Madrid

France · 3 centers

• CHU Rennes, Pontchaillou — Rennes
• Centre Médico Chirurgical Marie Lannelongue — Le Plessis-Robinson
• Hopital Haut Leveque — Pessac

United Kingdom · 2 centers

• Royal Brompton Hospital — London
• St. Thomas Hospital — London

Denmark · 1 center

• Odense University Hospital — Odense

Estonia · 1 center

• Tartu University Hospital — Tartu

Ireland · 1 center

• Children's Health Ireland (CHI) — Crumlin

Poland · 1 center

• Slaskie Centrum Chorob Serca — Zabrze

Identifiers

NCT: NCT06590467 · ABT-CIP-10415

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗