Abbott Structural Heart Device Registry

NCT06590467 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10415
• Study Type: observational
• Target: 2,500
• Locations: 9 countries
• Sites: 27

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.

Conditions

ASD - Atrial Septal Defect; PFO - Patent Foramen Ovale; Valvular Heart Disease; Heart Diseases; VSD - Muscular Ventricular Septal Defect; PIVSD - Post Infarct Muscular Ventricular Septal Defect

Keywords

Amplatzer; 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; Amplatzer Occluder devices; 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Epic™ Surgical Tissue Heart Valve devices DEVICE

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

Cardiac Surgery

Amplatzer™ Occlusion Devices DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (28)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

NOT YET RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

NOT YET RECRUITING

Odense University Hospital

Odense, Southern Denmark, 5000, Denmark

RECRUITING

Tartu University Hospital

Tartu, Tartu, 50406, Estonia

RECRUITING

CHRU Hopital de Pontchaillou

Rennes, Brittan, 35033, France

RECRUITING

Centre Médico Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

Hopital Haut Leveque

Pessac, 33604, France

RECRUITING

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, 80636, Germany

RECRUITING

Klinikum Links der Weser

Bremen, Free Hanseatic City of Bremen, 28277, Germany

RECRUITING

Universitatsklinikum Jena

Jena, Germany, 07747, Germany

RECRUITING

Städt. Klinikum Braunschweig gGmbH

Braunschweig, L Saxon, 38126, Germany

RECRUITING

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

RECRUITING

Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG

Bad Rothenfelde, 32545, Germany

RECRUITING

Children's Health Ireland (CHI)

Crumlin, Dublin, D12N512, Ireland

RECRUITING

IRCCS Policlinico San Donato - Cardio

San Donato Milanese, Lombardy, 20097, Italy

RECRUITING

Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

RECRUITING

A.O.U. Citta della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

RECRUITING

Slaskie Centrum Chorob Serca

Zabrze, Silesian Voivodeship, 41-800, Poland

RECRUITING

Hospital Infantil Sant Joan De Deu

Esplugues de Llobregat, Catalonia, 08950, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Virgen de Rocio

Seville, Spain, 41013, Spain

RECRUITING

Hospital Universitario de la Paz - Pediatrico

Madrid, 28046, Spain

RECRUITING

Royal Brompton Hospital

London, UK, SW3 6NP, United Kingdom

RECRUITING

St. Thomas Hospital

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Heart Septal Defects, Atrial; Foramen Ovale, Patent; Heart Valve Diseases

Interventions

Septal Occluder Device

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Ryan Palmer

  Abbott

  STUDY DIRECTOR

Central Study Contacts

Laetitia Beullens

CONTACT

+32 277 46 937; laetitia.beullens@abbott.com

Kayla Dellefratte

CONTACT

+16692149748; kayla.dellefratte@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): November 1, 2039
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

DK (1); FR (3); IE (1); GB (2); IT (4); US (5); DE (6); PL (1); ES (4)