Evaluation of PET/MR in Patients Selected for Ablation Therapy



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 80
Updated:3/8/2019
Start Date:July 1, 2016
End Date:June 1, 2023

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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 correctly. Irregular heart rate can be related to numerous diseases. One
category of irregular heart rate is called ventricular arrhythmia. It is often seen in
patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause
sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the
source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation
does not fix the problem in 100% of patients and some will still have the arrhythmia
requiring repeated procedure. The purpose of this study is to find new ways of guiding the
doctors performing ablation, hoping to improve the success rate of the procedure.


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;
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-1967
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mi
from
Boston, MA
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