MARVEN: Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy
Brief description of study
The purpose of this study is to
learn what clinical, cardiac magnetic resonance imaging (CMR), and ECG factors
could better identify which nonischemic cardiomyopathy (NICM)
patients might develop rapid irregular
heartbeats. This would then better identify who needs to get a CRT-D device. The
study enrolls patients with NICM whose provider has recommended they receive an
implantable cardioverter-defibrillator (ICD) or cardiac resynchronization
therapy defibrillator (CRT-D) implant.
Detailed description of study
Patients can be enrolled either prior to receiving an ICD or
CRT-D or if they have already received an ICD or CRT-D after July 1, 2018.
For participants enrolled prior to receiving their implant,
required study procedures include wearing a heart monitor (Holter) for 24
hours, obtaining a blood sample, and having a CMR scan.
For participants enrolled after receiving their implant,
study procedures include collecting medical history and reprogramming the
device to make sure it meets study requirements (if needed).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Nonischemic Cardiomyopathy
-
Age: Between 21 Years - 100 Years
-
Gender: All
Prior to ICD or CRT-D Implant Inclusion Criteria:
- Receiving optimal drug treatment for at least 3 months after NICM diagnosis
- Confirmed nonischemic dilated cardiomyopathy
meeting study criteria
- Willing to undergo CRT-D implant within 3 months
prior to consent
- Existing CMR within 12 months prior to consent
or willing to undergo CMR imaging prior to implant
Prior to ICD or CRT-D Implant Exclusion Criteria:
- History or imaging of NICM due to other known causes such as amyloidosis, cardiotoxicity due to chemotherapy, or hypertrophic cardiomyopathy
- History
of prior heart attack and certain coronary artery procedures
Preexisting ICD or CRT-D Implant Inclusion Criteria:
- ICD
or CRT-D implant after July 1, 2018
- Nonischemic
dilated cardiomyopathy confirmed by ECG within 12 months prior to implant
- Devices
with remote interrogation option on and interrogation reports available from
time of implant
- CMR imaging available from within 12 months prior to implant
Preexisting ICD or CRT-D Implant Exclusion Criteria (in
addition to same criteria listed above for new implants):
- No
available CMR imaging
- Any
medical condition likely to limit survival to < 1 year
- Participation
in other clinical trials that will affect the objectives of this study
- Inability
or unwillingness to provide informed consent
Updated on
09 Mar 2024.
Study ID: 2019-9
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