PET/MR Imaging for Cardiac Arrhythmias

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 21 and 80 years old.

Subjects must provide informed consent prior to study procedures

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

Exclusion Criteria

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

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

I have a heart condition like a previous heart attack.

Treatment Details

Interventions

18F-TPP (Radiopharmaceutical)

Trial OverviewThe 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.

Participant Groups

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