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PET/MR Imaging for Cardiac Arrhythmias

Phase 2

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be ≥21 and ≤80 years of age

History of scar-mediated ventricular arrhythmia scheduled for invasive EAM-guided catheter ablation for clinical care

Must not have

Any contraindication to MRI and/or PET, including subjects with life vest, implanted heart device (e.g. ICD, Pacemaker), metallic fragment or foreign body, other form of devices or prosthesis that are not MRI compatible, claustrophobia, history of renal disease including acute or chronic severe renal insufficiency, 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 to be incompatible with the study, radiation exposure exceeds current Radiology Department guidelines, 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

History of ventricular arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether PET-MR imaging can improve treatment for heart failure and irregular heart rate.

Who is the study for?

This trial is for adults aged 21-80 with a history of scar-mediated ventricular arrhythmia who are scheduled for ablation therapy. They must be able to consent and have no structural heart disease, MRI/PET contraindications, severe kidney issues, diabetes, lupus, or certain other conditions. Pregnant or lactating women cannot participate.

What is being tested?

The study tests if PET-MR imaging can help doctors perform ablation more successfully in patients with irregular heart rates due to ventricular arrhythmias. The goal is to improve the procedure's success rate and reduce the need for repeat treatments.

What are the potential side effects?

Potential side effects may include reactions to the PET-MR contrast agent like Dotarem (gadolinium-based), which could cause allergic responses or discomfort at the injection site. There might also be risks associated with exposure to radiation during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 80 years old.

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I am scheduled for a procedure to treat irregular heartbeats caused by scar tissue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health conditions or devices that prevent MRI or PET scans.

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I have had irregular heartbeats from the lower chambers of my heart.

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I have a heart condition like a previous heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

TPP imaging in Ventricular Arrhythmia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment FailureExperimental Treatment1 Intervention

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

Group II: ArrhythmiaExperimental Treatment1 Intervention

This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment

Group III: ControlActive Control1 Intervention

Normal subjects without history of cardiac disease or arrhythmia

0 / 5Eligibility criteria met