No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 and older
Sex
Any
Study type
Observational
Participants needed
36 (estimated)
Sponsor
Rocket Pharmaceuticals Inc. · Industry
Who this trial is looking for
This trial is looking for people aged 12 and older who have been diagnosed with Arrhythmogenic Cardiomyopathy caused by specific genetic changes. Participants will contribute to understanding the condition's progression and current management practices.
Are You a Good Fit for This Trial?
You may be able to join if
I am 12 years old or older.
I can give signed consent.
I have been diagnosed with arrhythmogenic cardiomyopathy.
I have a documented genetic change in PKP2.
I had an ICD implanted at least 6 months ago.
My heart's left ventricular ejection fraction is 50% or higher.
You may not be able to join if
My genetic testing shows my condition is not related to PKP2.
I am currently part of another clinical trial.
I have participated in gene transfer or gene editing studies before.
I have Class IV heart failure.
I need mechanical circulatory support or a heart transplant soon.
I have had an organ transplant.
I have a pacemaker rhythm documented in the last year.
I tested positive for HIV.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria
Patients must meet all the following criteria (and none of the exclusion criteria) to be eligible for study participation:
1. Male or female age 12 years or older at the time of providing informed consent (i.e., ICF provision).
2. Capable and willing to provide signed informed c…
Inclusion Criteria
Patients must meet all the following criteria (and none of the exclusion criteria) to be eligible for study participation:
1. Male or female age 12 years or older at the time of providing informed consent (i.e., ICF provision).
2. Capable and willing to provide signed informed consent and/or assent, which includes compliance with the requirements and restrictions listed in the ICF and protocol.
3. Clinical diagnosis of arrhythmogenic cardio myopathy (ACM)
4. Documentation of a pathogenic or likely pathogenic variant in PKP2 by a CLIA-certified genetic testing laboratory
5. History of ICD implantation ≥6 months prior to ICF provision
6. Left ventricular ejection fraction by echocardiogram or cardiac magnetic resonance (CMR) ≥50% at ≤12 months prior to ICF provision
Exclusion Criteria
Patients meeting any of the following criteria are excluded from study participation:
1. Gene testing indicates that the subject's arrhythmia or cardiomyopathy may be related to a genetic etiology other than PKP2 truncating variant.
2. Concurrent participation in any other clinical investigation involving use of an investigational agent that could confound results of this study.
3. Previous participation in a study of gene transfer or gene editing.
4. NYHA Class IV heart failure.
5. Presence or requirement for mechanical circulatory support (MCS) or predicted need for MCS or heart transplantation within 6 months of enrollment.
6. Prior cardiac or other organ (lung, liver, other) transplantation.
7. Pacemaker dependent rhythm documented, as assessed by the principal investigator ≤12 months prior to enrollment.
8. Positive human immunodeficiency virus (HIV) antibody test.
9. Unwillingness to comply with study procedures, including follow-up as specified by this protocol, or unwillingness to fully cooperate with the investigator.
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