PET/CT Imaging-Guided Ablation for Rapid Heartbeat

Overseen By Khaled Awad

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mercy Research

Disqualifiers: Right ventricular VT, Polymorphic VT, Recent myocardial infarction, Prosthetic valve, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

11 Participants Needed

Trial Summary

What is the purpose of this trial?

Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.

Eligibility Criteria

This trial is for individuals with a type of heart condition called cardiomyopathy who experience rapid, regular heartbeats known as sustained monomorphic ventricular tachycardia. They must have had at least one episode despite medication or choose not to take such drugs. Excluded are those with recent heart attacks, prior ablation, certain types of VT, inability to consent, pregnancy, and contraindications to imaging or anticoagulation therapy.

Inclusion Criteria

I have had at least one episode of a fast heartbeat that needs treatment despite taking medication, or I choose not to take these medications.

You have a specific type of heart rhythm problem called sustained monomorphic ventricular tachycardia.

I have a heart condition that affects how my heart muscle functions.

Exclusion Criteria

You are unable to have a device placed to help with your heart function, such as having a mechanical heart valve or not having suitable blood vessel access.

I am willing and able to follow the study's requirements.

You have an artificial valve in your heart.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Imaging is performed using PET/CT with [C-11] MHED tracer prior to the ablation procedure

1 week

1 visit (in-person)

Ablation Procedure

Ablation procedure is guided by the PET/CT imaging to correlate anatomy with physiology

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ablation procedure

4 weeks

Treatment Details

Interventions

• Cardiac PET/CT Imaging
• Ventricular Tachycardia Ablation

Trial Overview The study tests the use of PET/CT cardiac imaging with a special dye before an ablation procedure for ventricular tachycardia. The goal is to see if merging these scans with other cardiac images helps guide the treatment more accurately by correlating anatomy and physiology.

Participant Groups

Group I: Single Arm - PET/CT Imaging With [C-11] MHED Experimental Treatment 1 Intervention

Single Arm - positron emission tomography/computed tomography imaging with \[C-11\] meta-Hydroxyephedrine tracer

Who Is Running the Clinical Trial?

Mercy Research

Lead Sponsor

Trials

21

Recruited

1,400+

Khaled Awad, MD

Lead Sponsor

Trials

1

Recruited

10+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Biosense Webster, Inc.

Industry Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University