Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Summary

This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.

Conditions

• Arrhythmogenic Right Ventricular Cardiomyopathy

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• New York University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Hopital Louis Pradel

  collaborator OTHER

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• The Queen Elizabeth Hospital

  collaborator OTHER

• St George's University Hospitals NHS Foundation Trust

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Centro Cardiologico Monzino

  collaborator OTHER

• Hôpital Haut-Lévêque

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Pitié-Salpêtrière Hospital

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• University Hospital Muenster

  collaborator OTHER

• Tenaya Therapeutics

  lead INDUSTRY

Eligibility

Min Age

14 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-31

Primary Completion

2030-03-29

Completion

2030-07-11

Countries

• United States
• France
• Germany
• Italy
• Sweden
• United Kingdom

Study Locations