Evaluation of PET/MR in Patients Selected for Ablation Therapy
Arrhythmias, Cardiac
About this trial
This is an interventional diagnostic trial for Arrhythmias, Cardiac
Eligibility Criteria
Healthy Volunteers
Inclusion Criteria:
- Subjects must be ≥21 and ≤80 years of age;
- Subjects must provide informed consent prior to study procedures;
Exclusion Criteria:
- Known structural heart disease (e.g. myocardial infarction);
- History of ventricular arrhythmia;
- Any contraindication to MRI and/or PET, including:
- Subjects with life vest;
- Subjects with implanted heart device (e.g. ICD, Pacemaker);
- Subjects with metallic fragment or foreign body;
- Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
- Claustrophobia;
- Relative or absolute contraindication to Dotarem contrast:
- history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate <60 mL/min/1.73m2);
- a history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
- History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent
- Any clinically significant acute or unstable physical or psychological disease, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
- Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination
- Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
- Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
- Inability to provide written informed consent;
Arrhythmia Subjects:
Inclusion criteria
- Subjects must be ≥21 and ≤80 years of age;
- Subjects must provide informed consent prior to study procedures;
- History of scar-mediated ventricular arrhythmia scheduled for invasive EAM-guided catheter ablation for clinical care
Exclusion criteria
- Any contraindication to MRI and/or PET, including:
- Subjects with life vest;
- Subjects with implanted heart device (e.g. ICD, Pacemaker);
- Subjects with metallic fragment or foreign body;
- Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
- Claustrophobia;
- Relative or absolute contraindication to Dotarem contrast:
- history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate <60 mL/min/1.73m2);
- history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
- History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent;Any clinically significant acute or unstable physical or psychological disease, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
- Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination
- Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
- Female subjects only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
- Inability to provide written informed consent;
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control
Arrhythmia
Treatment Failure
Normal subjects without history of cardiac disease or arrhythmia
This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment
A subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T