Abbott Vascular Medical Device Registry

Last updated: June 14, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Circulation Disorders

Myocardial Ischemia

Treatment

Pacing catheters

Measurement and imaging (FFR and OCT)

Vascular plugs

Clinical Study ID

NCT04573660
ABT-CIP-10349
  • Ages > 18
  • All Genders

Study Summary

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is at least 18 years of age.

  2. Subject has a planned procedure, or underwent a procedure, that will use/used one ormore Abbott target devices covered in this registry.

  3. Subject is willing and able to comply with, or has already completed, the follow-upschedule specified in this protocol.

  4. Subject must provide written informed consent prior to any clinicalinvestigation-related data collection or be enrolled under an IRB/EC approved waiverof consent.

Exclusion

Exclusion Criteria:

  1. Subject has active symptoms and/or a positive test result of COVID-19 or otherrapidly spreading novel infectious agent within the prior 2 months of the date ofprocedure.

Study Design

Total Participants: 3784
Treatment Group(s): 9
Primary Treatment: Pacing catheters
Phase:
Study Start date:
October 25, 2020
Estimated Completion Date:
November 30, 2031

Connect with a study center

  • Perth Institute of Vascular Research

    Nedlands, WAUS 6009
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, WAUS 6009
    Australia

    Active - Recruiting

  • Universitätsklinik Graz

    Graz, Styria 8036
    Austria

    Active - Recruiting

  • Onze-Lieve-Vrouwziekenhuis Campus Aalst

    Aalst, Eflndrs 9300
    Belgium

    Active - Recruiting

  • AZ Sint-Blasius Ziekenhuis

    Dendermonde, Eflndrs 9200
    Belgium

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejian 321000
    China

    Active - Recruiting

  • Ningbo First Hospital

    Ningbo, Zhejian 315000
    China

    Active - Recruiting

  • CH Chartres

    Chartres, Centre 28018
    France

    Active - Recruiting

  • Hôpital Paris Saint-Joseph

    Paris, Ile 75014
    France

    Completed

  • Cardioangiologisches Centrum am Bethanien Krankenhaus

    Frankfurt, Hesse 60389
    Germany

    Active - Recruiting

  • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

    Mainz, Rhinela 55131
    Germany

    Active - Recruiting

  • Herz- u. Gefäßzentrum Bad Bevensen

    Bad Bevensen, Saxon 29549
    Germany

    Active - Recruiting

  • Universitätsklinikum Leipzig AÖR

    Leipzig, Saxony 04103
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schlesw 24105
    Germany

    Active - Recruiting

  • Semmelweis University

    Budapest, 1122
    Hungary

    Active - Recruiting

  • Centro Cardiologico Monzino

    Milano, Lombard 20138
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, Lombard 20132
    Italy

    Completed

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht 3435 CM
    Netherlands

    Completed

  • Hospital Universitari Vall d'Hebron

    Barcelona, Catalon 08035
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, Valncia 03010
    Spain

    Active - Recruiting

  • Hospital Universitario de la Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Kantonsspital Aarau

    Aarau, Basel 5001
    Switzerland

    Active - Recruiting

  • Inselspital - University Hospital of Bern

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, Mtaiwan 40705
    Taiwan

    Active - Recruiting

  • Cathay General Hospital

    Taipei City, Ntaiwan 106
    Taiwan

    Active - Recruiting

  • Chi Mei Hospital

    Tainan City, Staiwan 710
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan City, Staiwan 704
    Taiwan

    Active - Recruiting

  • Al Qassimi Hospital

    Sharjah, 3500
    United Arab Emirates

    Active - Recruiting

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • Arkansas Heart Hospital

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Bryan Heart

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee 37660
    United States

    Active - Recruiting

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