Abbott Structural Heart Device Registry

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Abbott Medical Devices
Study ID
NCT06590467
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amplatzer™ Occlusion Devices — DEVICE
    The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
  • 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.

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Aug 21, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Nov 30, 2039

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 7 days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901
Leonard Lee, MD
Leonard Lee, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Ismail El-Hamamsy, MD
Ismail El-Hamamsy, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Chase Brown, MD
Chase Brown, MD (PRINCIPAL_INVESTIGATOR)
UPMCPittsburghPennsylvania15213
Derek Serna Gallegos, MD
Derek Serna Gallegos, MD (PRINCIPAL_INVESTIGATOR)
Sentara Norfolk General HospitalNorfolkVirginia23507
Clinton Kemp, MD
Clinton Kemp, MD (PRINCIPAL_INVESTIGATOR)

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