PET/CT Imaging-Guided Ablation for Rapid Heartbeat

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat rapid heartbeats using advanced imaging techniques. Before treatment, doctors will use PET/CT scans to gain a detailed view of the heart. This aids in understanding the heart's anatomy and function during the ventricular tachycardia ablation procedure, which aims to correct the fast heartbeat. Individuals who have experienced at least one episode of a fast heartbeat that hasn't improved with medication, or who prefer not to continue medication, might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants may be on antiarrhythmic drug therapy, so you might be able to continue those medications.

What prior data suggests that PET/CT imaging is safe for cardiac procedures?

Research has shown that cardiac PET/CT imaging using the [C-11] MHED tracer has been tested in people. Early results suggest that the tracer is safe and does not cause harm shortly after injection. It moves through the body predictably, which is promising.

Less information is available about the safety of the ablation procedure. However, since this trial is in an early stage, researchers are closely monitoring the treatment to ensure safety. Early trials typically focus on assessing a treatment's safety and identifying any side effects.

In summary, while initial studies indicate that PET/CT imaging with [C-11] MHED appears safe, the safety of combining this imaging with the ablation treatment remains under investigation. Researchers will closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using PET/CT imaging-guided ablation for treating rapid heartbeats, like ventricular tachycardia, because it offers a more precise and targeted approach. Unlike traditional treatments, which often rely on electrical mapping to guide ablation, this method uses PET/CT scans with a special tracer called [C-11] meta-Hydroxyephedrine. This tracer helps to accurately pinpoint the problematic heart tissue responsible for the rapid heartbeat. By enhancing the precision of ablation, this technique has the potential to improve outcomes and reduce the risk of complications compared to current standard practices.

What evidence suggests that PET/CT imaging-guided ablation is effective for rapid heartbeat?

Research has shown that cardiac PET/CT imaging with [C-11] MHED, which participants in this trial will receive, helps doctors obtain clear images of the heart's nerves. This is crucial for treating rapid heartbeat issues such as ventricular tachycardia. Studies indicate that these images can better predict the risk of sudden cardiac arrest. The special dye used in the scans, [C-11] MHED, highlights nerve areas that may not function properly. This imaging enables doctors to perform heart treatments with greater accuracy and effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8041672/

Procedural recommendations of cardiac PET/CT imaging With this document, we provide a standard for PET/(diagnostic) CT imaging procedures in cardiovascular diseases that are inflammatory, infective, ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.121.012549

Positron Emission Tomography Imaging of Regional ... Regional denervation volume has superior cause-specific mortality prediction for SCA versus global parameters of sympathetic innervation.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4484581/

Cardiac PET-CT for Monitoring Medical and Interventional ... This review focuses on optimal use of PET and PET-CT in monitoring medical and interventional therapy in patients with CAD.

4. researchgate.net researchgate.net/publication/263935912_11C-mHED_for_PET_CT_Principles_of_Synthesis_Methodology_and_First_Clinical_Applications

(PDF) 11C-mHED for PET / CT: Principles of Synthesis ... In this paper we present our preliminary results showing the radiotracer bio-distribution in humans 10 minutes post injection. The present study ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/56/Supplement_4/3S

Introduction to Cardiac Neuronal Imaging: A Clinical Perspective The main imaging agents in this field, 123I-MIBG and 11C-MHED, have both been widely studied for 30 y, and 123I-MIBG has been used in clinical ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0914508725000176

Molecular imaging of cardiovascular disease This review presents representative tracers that are currently applied in clinical practice and emerging in clinical studies, focusing on imaging “A: arteries ...

7. ctv.veeva.com ctv.veeva.com/study/study-of-cardiac-pet-ct-imaging-to-guide-ablation-treatment-of-ventricular-tachycardia

Study of Cardiac PET/CT Imaging to Guide Ablation Treatment ... Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2828569/

Cardiac PET-CT: advanced hybrid imaging for the ... Cardiac PET-CT is a new hybrid imaging technique in the evaluation of patients suspected of CAD. In a single scanning session, complementary information on ...