Point Ablation Catheter for Ventricular Tachycardia

(FOCUS PFA Trial)

Recruiting at 1 trial location

Overseen By Devin Chamberlain, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vivek Reddy

Disqualifiers: Heart failure, Coronary artery disease, Aortic stenosis, others

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

Compensation: Varies

Number of Visits: 4

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with premature ventricular contractions (PVCs) or symptomatic sustained monomorphic ventricular tachycardia, a specific type of irregular heartbeat. The goal is to determine if a point ablation catheter can safely and effectively address these heart issues using pulsed field energy. Participants are those already scheduled for a procedure to treat their PVCs or ventricular tachycardia symptoms. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to innovative treatments for heart rhythm disorders.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a documented intracardiac thrombus, it must be dissolved with anticoagulation before participating, which suggests some medication adjustments might be necessary.

What prior data suggests that this point ablation catheter is safe for ventricular arrhythmia treatment?

Research has shown that using special tubes called ablation catheters to treat ventricular tachycardia is generally safe. In one study, 1.7% of patients passed away within 30 days after their first procedure, indicating that only a small number experienced serious problems soon after treatment. Another study found no major safety concerns with a temperature-controlled catheter, with all patients doing well in the short term. It is important to note that these findings are from similar treatments, not exactly the one in this trial. However, they suggest that such procedures are usually well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Point Ablation Catheter for ventricular tachycardia because it offers a potentially more precise and effective approach than standard ablation techniques. Unlike traditional catheters, the Point Ablation Catheter, known as Farapoint, is designed to target and treat arrhythmias with increased accuracy. This precision could lead to better outcomes, reducing the recurrence of arrhythmias and minimizing damage to surrounding heart tissue. By honing in on problem areas more effectively, this catheter could revolutionize how we manage ventricular tachycardia, offering hope for improved patient results.

What evidence suggests that this point ablation catheter is effective for ventricular arrhythmias?

Research has shown that catheter ablation, a procedure to correct irregular heartbeats, can effectively treat fast heartbeats known as ventricular tachycardia. In several studies, about 65.5% of patients who underwent this procedure experienced complete success, with their irregular heartbeats corrected. One study found that successful ablation led to better overall health outcomes for patients. Additionally, some research indicated that 70% of patients had successful testing for ventricular tachycardia during follow-up. These findings suggest that using a point ablation catheter, like the one tested in this trial, could effectively treat irregular heart rhythms. ^{3 6 7 8 9}

Who Is on the Research Team?

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with irregular heartbeats, specifically those who experience premature ventricular contractions or non-life-threatening ventricular tachycardia. Participants should have a history of these arrhythmias that are not adequately controlled by medications.

Inclusion Criteria

I am scheduled for a procedure to treat my irregular heartbeats.

I am over 18 years old.

I am scheduled for a procedure to treat irregular heartbeats.

Exclusion Criteria

Pregnancy or anticipated pregnancy during study follow-up

My heart irregularities are due to reversible conditions like electrolyte imbalances.

I have a severe narrowing of my heart's aortic valve.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedural Testing

Subjects will undergo brief pre-procedural testing before the ablation procedure

1 week

Ablation Procedure

All patients will undergo a standard ablation protocol using the study catheter (Farapoint)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Point Ablation Catheter

Trial Overview

The study is testing the effectiveness of a new technique using a point ablation catheter (Farapoint) to treat focal ventricular arrhythmias. It uses pulsed field energy to target and stop the abnormal electrical signals causing the irregular heartbeat.

How Is the Trial Designed?

Group I: Ablation using study catheter Experimental Treatment 1 Intervention

All patients will undergo a standard ablation protocol using the study catheter (Farapoint)

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials

23

Recruited

5,700+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

In a prospective trial involving 11 patients with recurrent ventricular tachycardia (VT), stereotactic arrhythmia radioablation (STAR) demonstrated a safety profile with only one patient experiencing a significant treatment-related adverse event, indicating it is a relatively safe option for this condition.

STAR resulted in an 84.3% reduction in VT burden among evaluable patients, suggesting it is an effective treatment for selected patients with VT, although many experienced recurrence and further interventions were needed, highlighting the need for long-term outcome studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. Miszczyk, M., Sajdok, M., Bednarek, J., et al.[2023]

Catheter ablation is an effective treatment for ventricular tachycardia (VT), particularly using the antegrade transseptal approach with a high-resolution basket catheter.

High-resolution mapping can rapidly produce detailed voltage and activation maps, aiding in the identification of critical VT substrates, even in patients with extensive scar tissue and unstable VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of hemodynamically unstable ventricular tachycardia in ischemic cardiomyopathy using high-resolution mapping. Kaiser, L., Jularic, M., Akbulak, RÖ., et al.[2020]

Implantable cardioverter defibrillators can reduce mortality in high-risk patients with ventricular tachyarrhythmias, but they do not cure the condition, as the risk of arrhythmia recurrence remains unchanged.

Recent advancements in catheter ablation techniques have improved the effectiveness of treating ventricular tachycardia, making it a potentially curative option for patients with structurally normal hearts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation for ventricular tachycardia. Lim, HS., Singleton, CB., Alasady, M., et al.[2010]

Catheter ablation has become the primary treatment for idiopathic ventricular tachycardia (VT) and is effective in reducing VT burden in patients with structural heart disease.

The treatment approach for VT is tailored based on patient symptoms, the risk of sudden death, and the balance of risks and benefits of available therapies, highlighting the importance of personalized medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of catheter ablation in the management of ventricular tachycardia. Tanawuttiwat, T., Nazarian, S., Calkins, H.[2017]

In a study of 1964 catheter ablations for ventricular arrhythmias, the overall major adverse event rate was 4.0%, with a lower complication rate in patients without structural heart disease (1.1% vs. 6.5%).

The RIVA Score was validated as a predictive tool for major complications, and incorporating additional factors like age and NYHA Class ≥ III improved its predictive accuracy for complications during ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors for major in-hospital complications after catheter ablation of ventricular arrhythmias: validation and modification of the Risk in Ventricular Ablation (RIVA) Score. Doldi, F., Doldi, PM., Plagwitz, L., et al.[2023]

Catheter ablation has become a standard and effective treatment for ventricular tachycardias over the past 20 years, with detailed discussions on its technical strategies and necessary diagnostic tests.

The review emphasizes that catheter ablation should be considered earlier in treatment for patients with ventricular tachycardias, regardless of whether they have structural heart disease, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Catheter ablation of ventricular tachycardias]. Mihálcz, A., Szili-Török, T., Tóth, K.[2015]

In a study of 9699 hospitalizations for ventricular tachycardia (VT) ablation, adverse events (AEs) occurred in 8.5% of cases, with major AEs in 3.0% and a mortality rate of 1.1%, indicating that while VT ablation is generally safe, there are significant risks involved.

The study found that higher hospital procedural volumes (more than 25 cases per year) were associated with lower rates of AEs, suggesting that choosing experienced centers for VT ablation may enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. Katz, DF., Turakhia, MP., Sauer, WH., et al.[2023]

A total of 26,642 patients underwent catheter ablation procedures in Sweden from 2006 to 2015, with a median follow-up of 4.7 years, showing a shift towards more complex arrhythmias like atrial fibrillation (AF) and ventricular tachycardia (VT).

The study found that while the repeat ablation rate was highest for AF at 41% within 3 years, the overall rate of adverse events was low at 1.7%, indicating that catheter ablation is a relatively safe procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decade of catheter ablation of cardiac arrhythmias in Sweden: ablation practices and outcomes. Holmqvist, F., Kesek, M., Englund, A., et al.[2020]

Ablation of local abnormal ventricular activity (LAVA) in patients with scar-related ventricular tachycardia (VT) can be successfully achieved in about 70% of cases, leading to improved outcomes compared to cases where LAVA persists.

The strategy of LAVA elimination, supported by advanced imaging techniques, allows for effective ablation even in sinus rhythm, providing a clear endpoint for treatment and enhancing the overall efficacy of VT management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substrate mapping and ablation for ventricular tachycardia: the LAVA approach. Sacher, F., Lim, HS., Derval, N., et al.[2018]

Catheter ablation has become a key treatment for patients with ventricular arrhythmias, particularly ventricular tachycardia (VT), improving management strategies.

The use of three-dimensional mapping systems in catheter ablation allows for precise identification of VT circuits, leading to better understanding of arrhythmia mechanisms and potentially improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Focal" ventricular tachycardia: insights from catheter ablation. Mittal, S.[2016]

In a study of 548 patients undergoing 722 catheter ablation procedures for ventricular tachycardias, major complications occurred in 6.2% of cases, with access site vascular complications being the most common (3.6%).

Patients with structural heart disease, older age (>70 years), and renal insufficiency were identified as independent predictors of complications, while postprocedural mortality was linked to early recurrence of ventricular tachycardia and ablation for electrical storm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of catheter ablation of ventricular tachycardia: a single-center experience. Peichl, P., Wichterle, D., Pavlu, L., et al.[2014]

The Lynx(TM) robotic radio frequency ablation catheter represents a significant advancement in catheter ablation for ventricular tachycardia (VT), enhancing precision and stability during procedures.

This innovative technology reduces operator fatigue and X-ray exposure, making the ablation process safer and potentially more efficient for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotically assisted ventricular tachycardia substrate modification ablation with the novel Lynx(TM) integrated sheath and RF ablation catheter. Lorgat, F., Pudney, E., van Deventer, H.[2013]

In a study of 518 patients with structural heart disease undergoing catheter ablation for ventricular tachycardia (VT), 10% experienced acute ablation failure, primarily due to anatomical challenges such as intramural and deep septal VT.

Acute ablation failure was found to significantly increase the risk of both mortality and VT recurrence, indicating that successful ablation is crucial for improving long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute failure of catheter ablation for ventricular tachycardia due to structural heart disease: causes and significance. Tokuda, M., Kojodjojo, P., Tung, S., et al.[2021]

In a study of 126 patients undergoing catheter ablation for ventricular tachycardia, endocardial catheter ablation alone achieved a high success rate of 94% for treating ventricular tachycardia, indicating its effectiveness as a primary treatment option.

Epicardial catheter ablation was only necessary in 6% of cases and was successful in 60% of those, suggesting it should be reserved for situations where endocardial ablation fails due to potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Necessity of epicardial ablation for ventricular tachycardia after sequential endocardial approach. Sultan, A., Lüker, J., Hoffmann, B., et al.[2015]

Citations

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ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.034814

Ten‐Year Outcomes and Predictors of Mortality Following ...

Estimated 10‐year all‐cause mortality following hospital discharge after catheter ablation of ventricular tachycardia was 39.4% in an all‐comer ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9691946/

Outcomes of catheter ablation of ventricular tachycardia in ...

A total of 5 observational studies reported outcomes in 666 patients with NIDCM undergoing VT CA. The complete procedural success was moderately high; 65.5% of ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2666501824003738

Clinical outcomes after ventricular tachycardia ablation ...

Median follow-up after initial ablation was 16 months. Thirty-nine of 56 patients (70%) in the induction group had VT induced successfully. The prevalence of ...

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nature.com

nature.com/articles/s41598-024-69467-4

Catheter ablation as first-line treatment for ventricular ...

Recent studies have shown that successful ablation is associated with better outcomes in patients with VT. In the study of Tung et al., it was ...

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nejm.org

nejm.org/doi/10.1056/NEJMoa2409501

Catheter Ablation or Antiarrhythmic Drugs for Ventricular ...

A total of 416 patients were followed for a median of 4.3 years. A primary end-point event occurred in 103 of 203 patients (50.7%) assigned to ...

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jacc.org

jacc.org/doi/10.1016/j.jacep.2020.07.028

Safety and Outcomes of Ventricular Tachycardia Substrate ...

Outcomes: early and late mortality. Thirty-day mortality after the first VT ablation procedure was 1.7% (n = 7). Of these, 3 patients died ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12399702/

Safety and efficacy of a temperature-controlled ablation ...

Ablation of VT using a temperature-controlled irrigated RF catheter was safe and effective with no primary safety event, 100% acute success, and ...

8.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.117.007045

Ablation Outcomes and Predictors of Mortality Following ...

Two‐year mortality was higher in patients with SHD (18.7% versus 3.5%, P<0.001). Predictors of mortality include age >60 years, incessant VT, ...

9.

academic.oup.com

academic.oup.com/europace/article/26/11/euae275/7853050

Mapping and ablation of ventricular tachycardia using dual ...

Ventricular-arrhythmia-free survival at three months was 78%. VT ablation using a dual-energy lattice-tip catheter and a novel ...