Status:
ACTIVE_NOT_RECRUITING
Evaluation of PET/MR in Patients Selected for Ablation Therapy
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
This study is performed to assess if PET-MR imaging can improve treatment of patients with irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too weak to do his work...
Eligibility Criteria
Inclusion
- Healthy Volunteers
- Subjects must be ≥21 and ≤80 years of age;
- Subjects must provide informed consent prior to study procedures;
Exclusion
- 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;
Key Trial Info
Start Date :
July 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03265431
Start Date
July 14 2017
End Date
June 30 2027
Last Update
January 30 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114