Recruiting

Observational Study

Sponsor:

Abbott Medical Devices

Code:

NCT06590467

Conditions

Heart Diseases

ASD - Atrial Septal Defect

VSD - Muscular Ventricular Septal Defect

PFO - Patent Foramen Ovale

PIVSD - Post Infarct Muscular Ventricular Septal Defect

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Amplatzer™ Occlusion Devices

Epic™ Surgical Tissue Heart Valve devices

Study Details

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

Heart Diseases

ASD - Atrial Septal Defect

VSD - Muscular Ventricular Septal Defect

PFO - Patent Foramen Ovale

PIVSD - Post Infarct Muscular Ventricular Septal Defect

Study ID

NCT06590467

Start date

Aug 21, 2024

Status verified date

Apr, 2026

Completion date

Nov, 2039

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

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
  • Piccolo Delivery System (PDS): 50 cases total
  • SB II:100 PFO cases/year \& 100 ASD cases/year
  • GW: 200 cases/year

Cardiac Surgery (The ENDURE Study)

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

Interventions

Amplatzer™ Occlusion Devices

The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.

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 measure

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

Central Contacts and Locations

Central contacts

Laetitia Beullens

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

Kayla Dellefratte

+16692149748kayla.dellefratte@abbott.com

Locations

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Leonard Lee, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Ismail El-Hamamsy, MD

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Derek Serna Gallegos, MD

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Principal Investigator:

Clinton Kemp, MD

More Information

Sponsor

Abbott Medical Devices

Last update posted

Sep 1, 2026

Last verified

Apr, 2026

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
  • Amplatzer Piccolo Delivery System
  • Epic Elite Aortic Valve
  • Epic Elite Mitral Valve
  • Epic Supra G3 Aortic Valve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-09-01.