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?

The purpose of this study is to understand why certain hearts have ventricular arrhythmias and help identify areas of the heart that cause arrhythmias. There is still a significant gap in understanding why ventricular arrhythmias occur. This study will examine the electrical properties of the heart tissue to understand how these arrhythmias occur, and hopefully identify areas that might lead to ventricular arrhythmias. The hope is that studying this might be able to improve outcomes during ventricular tachycardia (VT) ablations.

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 safety data is available for the MAP Catheter used in ventricular tachycardia treatment?

The safety data for the MAP Catheter in ventricular tachycardia treatment includes several studies. One study involving 23 patients with sustained ventricular tachycardia found that endocardial catheter mapping could be performed without complications, indicating a safe procedure. Another study on catheter ablation in a canine model showed that while mapping and ablation were feasible, there was a risk of initiating ventricular arrhythmias, although the damage was localized. Additionally, catheter ablation is considered an effective and safe treatment for ventricular tachycardia associated with structural heart disease, with guidelines developed from accumulated data. Overall, the MAP Catheter appears to be a safe method for mapping and treating ventricular tachycardia, though some risks exist, particularly in experimental models. ^{1 2 3 4 5}

Is the MAP Catheter safe for use in humans?

The MAP Catheter has been used in patients with ventricular tachycardia without complications, indicating it is generally safe when used carefully. However, in animal studies, high-energy discharges during catheter use caused localized damage and sometimes triggered arrhythmias, suggesting caution is needed. ^{1 2 3 4 5}

Is the MAP Catheter a promising treatment 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 to more effective treatments for heart rhythm problems. ^{6 7 8 9 10}

How does the MAP Catheter treatment for Ventricular Tachycardia differ from other treatments?

The MAP Catheter treatment is unique because it uses a catheter to record monophasic action potentials (MAPs), which are electrical signals from the heart, to guide the treatment of ventricular tachycardia. This approach allows for precise identification of local heart activity and can be used to guide catheter ablation, a procedure that destroys small areas of heart tissue causing abnormal rhythms, making it different from traditional treatments that may not use such targeted electrical mapping. ^{6 7 8 9 10}

What data supports the idea that MAP Catheter for Ventricular Tachycardia is an effective treatment?

The available research shows that catheter ablation, which includes the use of MAP Catheters, is an effective treatment for ventricular tachycardia, especially when related to structural heart disease. It reduces the risk of recurring irregular heartbeats and the need for defibrillator shocks. Compared to drugs, which are often the first choice but not very effective, catheter ablation offers a more reliable solution for those who need it. The research also highlights that using advanced mapping techniques can improve the success of the treatment. ^{2 11 12 13 14}

What data supports the effectiveness of the MAP Catheter treatment for ventricular tachycardia?

Research shows that catheter ablation, a similar treatment, is effective and safe for treating ventricular tachycardia, especially when combined with advanced mapping techniques to accurately target the problem areas in the heart. ^{2 11 12 13 14}

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

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation for management of symptomatic ventricular ectopic activity. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Mapping and ablation of ventricular tachycardia with the aid of a non-contact mapping system. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Catheter ablation of repetitive monomorphic ventricular tachycardia from left ventricular outflow tract guided by unipolar mapping. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. France pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a percutaneous catheter technique for ablation of ventricular tachycardia in a canine model. [2019]

7. Japan 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. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Contribution of body surface mapping to clinical outcome after surgical ablation of postinfarction ventricular tachycardia. [2019]

9. United States 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. [2019]

10. Mexico pubmed.ncbi.nlm.nih.gov

[Endocardial monophasic action potentials obtained by means of suction catheters]. [2012]

11. United States pubmed.ncbi.nlm.nih.gov

Monophasic action potentials: concepts to practical applications. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. Spain pubmed.ncbi.nlm.nih.gov

The monophasic action potential technique and its application in cardiac electropharmacology. [2007]

14. England pubmed.ncbi.nlm.nih.gov

Recording monophasic action potentials using a platinum-electrode ablation catheter. [2013]