Abbott Structural Heart Device Registry (SH-Registry)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Valvular Heart Disease; PFO - Patent Foramen Ovale; VSD - Muscular Ventricular Septal Defect; PIVSD - Post Infarct Muscular Ventricular Septal Defect; ASD - Atrial Septal Defect
• Intervention / Treatment: Device: Amplatzer™ Occlusion Devices; Device: Epic™ Surgical Tissue Heart Valve 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 Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Laetitia Beullens; Phone Number: +32 277 46 937; Email: laetitia.beullens@abbott.com
• Study Contact Backup: Name: Kayla Dellefratte; Phone Number: +16692149748; Email: kayla.dellefratte@abbott.com

Study Locations

• Denmark
  • Southern Denmark
    • Odense, Southern Denmark, Denmark, 5000
      • Recruiting
      • Odense University Hospital
      • Contact: Lars Peter Riber, Prof.
      • Principal Investigator: Lars Peter Riber, Prof.
• Estonia
  • Tartu
    • Tartu, Tartu, Estonia, 50406
      • Recruiting
      • Tartu University Hospital
      • Contact: Arno Ruusalepp, Prof.
      • Principal Investigator: Arno Ruusalepp, Prof.
• France
  • Le Plessis-Robinson, France, 92350
    • Recruiting
    • Centre Médico Chirurgical Marie Lannelongue
    • Contact: Sebastien Hascoet, Dr.
    • Principal Investigator: Sebastien Hascoet, Dr.
  • Pessac, France, 33604
    • Recruiting
    • Hopital Haut Lévêque
    • Contact: Zakaria Jalal, Dr.
    • Principal Investigator: Zakaria Jalal, Dr.
  • Brittan
    • Rennes, Brittan, France, 35033
      • Recruiting
      • CHRU Hôpital de Pontchaillou
      • Principal Investigator: Anselmi Amedeo
      • Contact: Amedeo Anselmi
• Germany
  • Bad Rothenfelde, Germany, 32545
    • Recruiting
    • Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
    • Contact: Nicolas Doll, Prof.
    • Principal Investigator: Nicolas Doll, Prof.
  • Bavaria
    • München, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum München des Freistaates Bayern
      • Contact: Stanimir Georgiev, Dr. med.
      • Principal Investigator: Stanimir Georgiev, Dr. med.
  • Free Hanseatic City of Bremen
    • Bremen, Free Hanseatic City of Bremen, Germany, 28277
      • Recruiting
      • Klinikum Links der Weser
      • Principal Investigator: Jens Garbade, Prof. Dr. med.
      • Contact: Jens Garbade, Prof. Dr. med.
  • Germany
    • Jena, Germany, Germany, 07747
      • Recruiting
      • Universitatsklinikum Jena
      • Contact: Torsten Doenst, Prof. Dr.
      • Principal Investigator: Torsten Doenst, Prof. Dr.
  • L Saxon
    • Braunschweig, L Saxon, Germany, 38126
      • Recruiting
      • Städt. Klinikum Braunschweig gGmbH
      • Principal Investigator: Ingo Breitenbach, Dr. med.
      • Contact: Ingo Breitenbach, Dr. med.
  • State of Berlin
    • Berlin, State of Berlin, Germany, 13353
      • Recruiting
      • Deutsches Herzzentrum der Charité
      • Contact: Peter Kramer, Dr. med.
      • Principal Investigator: Peter Kramer, Dr. med.
• Ireland
  • Dublin
    • Crumlin, Dublin, Ireland, D12N512
      • Recruiting
      • Children's Health Ireland (CHI)
      • Contact: Damien Kenny, Prof.
      • Principal Investigator: Damien Kenny, Prof.
• Italy
  • Lombardy
    • San Donato Milanese, Lombardy, Italy, 20097
      • Recruiting
      • Policlinico San Donato
      • Principal Investigator: Francesco Bedogni, MD
      • Contact: Francesco Bedogni, MD
    • San Donato Milanese, Lombardy, Italy, 20097
      • Recruiting
      • IRCCS Policlinico San Donato - Cardio
      • Contact: Angelo Fabio D'Aiello, MD
      • Principal Investigator: Angelo Fabio D'Aiello, MD
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • Recruiting
      • A.O.U. Città della Salute e Della Scienza di Torino
      • Contact: Giuseppe Annoni
      • Principal Investigator: Giuseppe Annoni
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Recruiting
      • Azienda Ospedaliero Universitaria Pisana
      • Principal Investigator: Andrea Colli, Prof.
      • Contact: Andrea Colli, Prof.
• Poland
  • Silesian Voivodeship
    • Zabrze, Silesian Voivodeship, Poland, 41-800
      • Recruiting
      • Slaskie Centrum Chorob Serca
      • Principal Investigator: Roland Fiszer, Prof.
      • Contact: Roland Fiszer, Prof.
• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario de la Paz - Pediatrico
    • Contact: Federico Gutierrez Larraya, Dr.
    • Principal Investigator: Federico Gutierrez Larraya, Dr.
  • Catalonia
    • Esplugues de Llobregat, Catalonia, Spain, 08950
      • Recruiting
      • Hospital Infantil Sant Joan De Deu
      • Contact: Juan Manuel Carretero Bellon
      • Principal Investigator: Juan Manuel Carretero Bellon
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias
      • Contact: Jacobo Silva Guisasola
      • Principal Investigator: Jacobo Silva Guisasola
  • Spain
    • Seville, Spain, Spain, 41013
      • Recruiting
      • Hospital Virgen de Rocio
      • Contact: Jose Miguel Borrego Dominguez, Dr
      • Principal Investigator: Jose Miguel Borrego Dominguez, Dr
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • St. Thomas Hospital
    • Contact: Matthew Jones, Dr.
    • Principal Investigator: Matthew Jones, Dr.
  • UK
    • London, UK, United Kingdom, SW3 6NP
      • Recruiting
      • Royal Brompton Hospital
      • Contact: Alain Fraisse, Dr.
      • Principal Investigator: Alain Fraisse, Dr.
• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Not yet recruiting
      • Robert Wood Johnson University Hospital
      • Contact: Leonard Lee, MD
      • Principal Investigator: Leonard Lee, MD
  • New York
    • New York, New York, United States, 10029
      • Not yet recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Ismail El-Hamamsy, MD
      • Contact: Ismail El-Hamamsy, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • University of Pennsylvania
      • Contact: Chase Brown, MD
      • Principal Investigator: Chase Brown, MD
    • Pittsburgh, Pennsylvania, United States, 15213
      • Not yet recruiting
      • UPMC
      • Principal Investigator: Ibrahim Sultan, MD
      • Contact: Ibrahim Sultan, MD
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Not yet recruiting
      • Sentara Norfolk General Hospital
      • Contact: Clinton Kemp, MD
      • Principal Investigator: Clinton Kemp, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 cohort: consent within 6 months (183 days) of the implant procedure)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Amplatzer; 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	Device: Amplatzer™ Occlusion Devices; The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.; Other Names: 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
Cardiac Surgery; 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	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.; Other Names: EMAX; E200; ESP200; Sizer Set Model E2000; Sizer Set Model EMAX-1000; Replacement Holder Handles E2000-HA and E2000-HM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Baseline

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Ryan Palmer, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): November 1, 2039

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Amplatzer; Amplatzer Occluder devices; 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 Sizing Balloon; Amplatzer Guidewire; Surgical Valves; Epic Plus Aortic Valve; Epic Plus Mitral Valve; Epic Plus Supra Aortic Valve; Epic Max Aortic Valve; Bioprosthetic heart valve; Surgical tissue heart valve
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Foramen Ovale, Patent; Heart Septal Defects, Atrial; Heart Valve Diseases; Equipment and Supplies; Prostheses and Implants; Septal Occluder Device
• Other Study ID Numbers: ABT-CIP-10415

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes