Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT06311708 · View on ClinicalTrials.gov ↗
Study 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 Studied
Study Locations (20)
Other
- Hopital Louis Pradel — Bron
- Nantes University Hospital — Nantes
- Pitié-Salpêtrière Hospital — Paris
- Hôpital Haut-Lévêque — Pessac
- University Hospital Muenster — Münster
- Wuerzburg University Hospital — Würzburg
- Centro Cardiologico Monzino — Milan
- Istituti Clinici Scientifici Maugeri SpA — Pavia
- Skåne University Hospital — Malmo
- The Queen Elizabeth Hospital — Glasgow
- Barts & The London Health NHS Trust — London
- St. George's University Hospitals NHS Foundation Trust — London
California
- University of California San Francisco — San Francisco
Colorado
- University of Colorado, Denver — Aurora
Maryland
- John Hopkins University School of Medicine — Baltimore
Massachusetts
- Brigham and Women's Hospital — Boston
Minnesota
- Mayo Clinic — Rochester
New York
- New York University — New York
Ohio
- Cleveland Clinic — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2030-07-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06311708
The ClinicalTrials.gov registry entry for NCT06311708 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tenaya Therapeutics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Arrhythmogenic Right Ventricular Cardiomyopathy appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06311708 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06311708 about?
NCT06311708 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT06311708?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2023-01-31. Estimated completion is 2030-07-11.
What conditions does trial NCT06311708 study?
This clinical trial studies the following conditions: Arrhythmogenic Right Ventricular Cardiomyopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT06311708?
This trial is sponsored by Tenaya Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06311708 being conducted?
This trial has 20 study locations across California, Colorado, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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