MAP Catheter for Ventricular Tachycardia

Recruiting at 2 trial locations

Overseen By Neal Bhatia, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Non-ischemic cardiomyopathy, severe arterial disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why some hearts develop abnormal rhythms, known as ventricular arrhythmias. Researchers will examine the heart's electrical signals using a special tool called the Monophasic Action Potential (MAP) catheter to pinpoint areas causing these irregular rhythms. The goal is to improve treatments for those undergoing procedures to correct these heart issues. People with a history of heart damage from reduced blood flow (ischemic cardiomyopathy) and who have a heart device like an ICD might be good candidates for this study. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance future heart treatments.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the MAP Catheter is safe for use in ventricular tachycardia procedures?

Research has shown that the Monophasic Action Potential (MAP) Catheter is generally safe for mapping and treating ventricular tachycardia, a fast heart rhythm. While some risks exist, they mostly appear in experimental settings. For instance, one study highlighted the MAP Catheter as a reliable tool for assessing the heart's electrical activity, crucial for understanding and treating irregular heartbeats.

However, it is important to note that, like any medical procedure, some risks may be involved. Studies indicate that results for treating ventricular tachycardia can vary, and improvements are ongoing. Overall, the MAP Catheter has shown promise in safely addressing heart rhythm problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for ventricular tachycardia, which often include medications or implantable devices like defibrillators, the Monophasic Action Potential (MAP) Catheter offers a unique approach by directly assessing the cellular action potential of the ventricular myocardium. This technique provides real-time, precise insights into the electrical activity of heart cells during ablation procedures. Researchers are excited about this catheter because it could enhance the accuracy and effectiveness of ablation therapy, potentially leading to better outcomes for patients with ventricular tachycardia.

What evidence suggests that the MAP Catheter is effective for ventricular tachycardia?

Research has shown that the Monophasic Action Potential (MAP) Catheter aids in understanding and treating Ventricular Tachycardia (VT), a type of irregular heartbeat. This trial will evaluate the MAP Catheter, which provides detailed information about the heart's electrical activity, crucial for identifying areas that might cause these irregular heartbeats. Studies have found that using the MAP Catheter during procedures can enhance the effectiveness of VT treatments. These treatments aim to destroy small parts of the heart that cause abnormal rhythms. By accurately mapping the heart's electrical signals, doctors can better target problem areas, potentially leading to improved outcomes for patients with VT. Overall, the MAP Catheter holds promise in managing and treating Ventricular Tachycardia by improving the precision of current treatment methods. ^{1 3 6 7 8}

Who Is on the Research Team?

Neal Bhatia, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for people with ischemic cardiomyopathy who have a single or dual chamber implantable cardioverter-defibrillator (ICD). It's not suitable for those with non-ischemic cardiomyopathy, contraindications to catheter ablation, severe arterial disease, or recent VT/SCA following acute coronary syndrome or revascularization.

Inclusion Criteria

I have been diagnosed with ischemic cardiomyopathy.

You have a specific type of heart device called a single or dual chamber implantable cardioverter-defibrillator (ICD).

Exclusion Criteria

I do not have severe artery problems that prevent medical procedures.

I had a rapid heartbeat or cardiac arrest shortly after a heart attack or heart procedure.

My heart condition is not caused by reduced blood flow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ventricular tachycardia ablation with the MAP catheter to assess cellular action potential of the ventricular myocardium

1 day

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

• Monophasic Action Potential (MAP) Catheter

Trial Overview The study is testing the use of a Monophasic Action Potential (MAP) Catheter to understand and identify heart tissue causing ventricular arrhythmias. The goal is to improve outcomes during VT ablations by studying electrical properties of the heart.

How Is the Trial Designed?

Group I: Monophasic Action Potential (MAP) Catheter Experimental Treatment 1 Intervention

Participants undergoing ventricular tachycardia ablation per standard of care will also have cellular action potential of the ventricular myocardium assessed with the MAP catheter.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Endocardial monophasic active potentials (M.A.P.) can be effectively recorded using suction-tip intracardiac catheters, providing a new method for studying cardiac arrhythmias and electrophysiology.

The M.A.P. recordings obtained with this method show results consistent with those from traditional intracellular microelectrodes, demonstrating its efficacy in evaluating the effects of various antiarrhythmic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Endocardial monophasic action potentials obtained by means of suction catheters]. Casellas Bernat, A., Crexells Figueras, C., Doxandabaratz Ilundain, JJ., et al.[2012]

Monophasic action potential (MAP) recordings are a highly accurate method for assessing myocardial repolarization changes, making them the preferred technique in clinical settings for evaluating heart function.

MAPs can be effectively recorded using a safer contact catheter technique during electrophysiology procedures and open heart surgery, allowing for detailed analysis of heart conditions such as ischemia and arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monophasic action potentials: concepts to practical applications. Yuan, S., Blomström-Lundqvist, C., Olsson, SB.[2019]

In a study involving 23 patients with recurrent sustained ventricular tachycardia (VT) and 14 patients with non-sustained VT, endocardial catheter mapping was performed safely without complications, demonstrating its feasibility in clinical settings.

The mapping allowed for the identification of multiple sites for local electrical activity recording and pacing, which is crucial for understanding and treating VT effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early experiences of endocardial catheter mapping of the left ventricle in patients with sustained ventricular tachycardia--efficacy, safety and complications. Aizawa, Y., Satoh, M., Suzuki, K., et al.[2019]

In a study of 54 patients undergoing ventricular antiarrhythmic surgery, preoperative body surface mapping was found to be effective, showing similar outcomes in arrhythmia freedom and survival compared to a control group of 30 patients who did not undergo this mapping.

The study indicated that 79% of ventricular tachycardias localized by both body surface mapping and catheter activation sequence mapping had similar exit sites, suggesting that body surface mapping can be a reliable method for optimizing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of body surface mapping to clinical outcome after surgical ablation of postinfarction ventricular tachycardia. van Dessel, PF., van Hemel, NM., Groenewegen, AS., et al.[2019]

Platinum electrodes in ablation catheters can effectively record monophasic action potentials (MAPs) during electrophysiological studies, showing stable baselines in 90% of ventricular and 100% of atrial recordings from 40 patients.

The recorded MAPs provided clearer local activation signals compared to traditional electrograms, indicating that using platinum electrodes for MAP-guided catheter ablation is both feasible and potentially advantageous for improving ablation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recording monophasic action potentials using a platinum-electrode ablation catheter. Yuan, S., Kongstad, O., Hertervig, E., et al.[2013]

Monophasic action potentials (MAPs) are a reliable and safe method for measuring the electrical activity of heart cells, which can be recorded directly from the heart's surface in both animals and humans.

The MAP technique is particularly useful for studying the effects of antiarrhythmic and antiischemic drugs, helping researchers understand their mechanisms of action in treating heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The monophasic action potential technique and its application in cardiac electropharmacology. Xie, JT., January, CT.[2007]

Catheter ablation is a safe and effective treatment for ventricular tachycardia caused by structural heart disease, significantly reducing the chances of recurrent arrhythmias and the need for defibrillator shocks.

Successful ablation relies on precise identification of the arrhythmia substrate and the use of both traditional and modern mapping techniques, highlighting the importance of thorough preoperative assessments before the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of ventricular tachycardia associated with structural heart disease: Current status and perspectives. Nakahara, S.[2023]

The new 'contact electrode' catheter technique allows for safe and continuous recording of monophasic action potentials (MAPs) from heart tissue during routine cardiac catheterization, providing valuable insights into local myocardial electrical activity.

MAP recordings, although smaller in amplitude than traditional transmembrane action potentials, show predictable phase relations and can effectively evaluate changes in myocardial repolarization in response to pacing, highlighting their potential utility in assessing heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term recording of monophasic action potentials from human endocardium. Franz, MR.[2019]

A non-contact mapping system was used in 24 patients with ventricular tachycardia (VT), successfully identifying exit sites for 80 out of 81 VT morphologies and achieving a 77% success rate in ablation, indicating its efficacy in treating VT.

Over a mean follow-up of 1.5 years, 14 patients experienced no recurrence of VT, demonstrating the safety and potential long-term effectiveness of this mapping technology for curative treatment of VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping and ablation of ventricular tachycardia with the aid of a non-contact mapping system. Schilling, RJ., Peters, NS., Davies, DW.[2019]

In a study involving 17 dogs, catheter ablation was effective in mapping and temporarily abating monomorphic ventricular tachycardia, demonstrating its potential as a treatment for arrhythmias.

High-energy discharges (300 J) used during the procedure caused localized heart tissue damage but also had a risk of triggering dangerous arrhythmias, indicating a need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a percutaneous catheter technique for ablation of ventricular tachycardia in a canine model. Chapman, PD., Klopfenstein, HS., Troup, PJ., et al.[2019]

Electroanatomic mapping during sinus rhythm can accurately characterize the 3D architecture of heart tissue after a heart attack, allowing for better identification of areas that may cause dangerous heart rhythms.

Infarcted tissue showed distinct electrogram characteristics compared to healthy tissue, which could help in developing targeted ablation strategies for treating ventricular tachycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroanatomic left ventricular mapping in the porcine model of healed anterior myocardial infarction. Correlation with intracardiac echocardiography and pathological analysis. Callans, DJ., Ren, JF., Michele, J., et al.[2019]

In a study of 10 patients with severe symptoms from drug-refractory monomorphic ventricular ectopic beats, radiofrequency catheter ablation successfully eliminated ectopic activity in all cases, demonstrating its efficacy as a treatment option.

No complications were reported during the procedure, and follow-up over an average of 10 months showed that most patients had no recurrence of symptoms, indicating the safety and long-term effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation for management of symptomatic ventricular ectopic activity. Zhu, DW., Maloney, JD., Simmons, TW., et al.[2019]

In a case of repetitive monomorphic ventricular tachycardia originating from the left ventricular outflow tract, using unipolar mapping criteria for catheter ablation led to a successful outcome with a shorter procedure time.

This approach contrasts with previous methods that required multiple applications based on activation or pace mapping, highlighting the potential efficacy and efficiency of unipolar mapping in treating this uncommon arrhythmia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of repetitive monomorphic ventricular tachycardia from left ventricular outflow tract guided by unipolar mapping. Asso, A., Pascual, ED., López, M., et al.[2019]

Sustained monomorphic ventricular tachycardia is a critical post-infarction arrhythmia that can be effectively assessed using programmed stimulation, which helps predict the long-term success of antiarrhythmic medications.

While antiarrhythmic drugs are the first-line treatment for this condition, their overall efficacy is limited; however, they provide a reliable and safe option for patients who respond to them, alongside other treatments like implantable cardioverter defibrillators and catheter ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-infarction sustained ventricular tachycardias. The role of drugs and methods for assessing antiarrhythmic efficacy. Campbell, RW.[2009]

Citations

1. withpower.com withpower.com/trial/phase-ventricular-tachycardia-vt-6-2022-02710

MAP Catheter for Ventricular Tachycardia Yes, the MAP Catheter is a promising treatment for Ventricular Tachycardia. It helps doctors understand the heart's electrical activity better, which can lead ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2813769/

Multiple Monophasic Shocks Improve Electrotherapy of ... The risk of arrhythmic death is found to be higher than that of non-arrhythmic death in patients over a two-year period after MI. Radiofrequency catheter ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666602225000643

Non-invasive mapping of ventricular action potential ... Monophasic action potential recordings. Four right ventricular monophasic action potentials were simultaneously recorded during uMCG mapping, with a single ...

4. academic.oup.com academic.oup.com/cardiovascres/article/41/1/25/316541

Current status of monophasic action potential recording This article attempts to review the available information on the MAP genesis and its particular recording modes.

5. mdpi.com mdpi.com/1873-149X/31/1/3

Opportunities and Challenges in Catheter-Based ... This comprehensive review will briefly summarize the pathophysiological mechanisms underlying VT and then summarize the pre-clinical and adult clinical data ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10801500/

Opportunities and Challenges in Catheter-Based ... One area of potential application for PFA is in the mitigation of ventricular tachycardia (VT) risk in the setting of ischemia-mediated myocardial fibrosis.

7. aerjournal.com aerjournal.com/articles/functional-substrate-mapping-new-frontier-treatment-ventricular-tachycardia-structural?language_content_entity=en

Functional Substrate Mapping | AER Journal However, despite significant improvements in mapping and ablation catheter technology, outcomes following VT ablation remain suboptimal, with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11997619/

Repolarization time map in catheter ablation for scar‐ ... This retrospective study analyzed 33 consecutive cases of catheter ablation for sustained VT. The EnSite system was employed to measure repolarization time (RT)