Pulse Field Ablation for Ventricular Tachycardia

(ASCEND-VT Trial)

Overseen By Pasquale Santangeli, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Idiopathic VT, NYHA class IV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Periprocedural

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to treat ventricular tachycardia (a fast heart rhythm) using pulse field ablation, a medical procedure. Researchers aim to determine if this method is safer and more effective than standard radiofrequency ablation. Participants will receive either the new treatment or the standard one to compare outcomes. Ideal candidates have ischemic heart disease and have experienced repeated episodes of ventricular tachycardia, even with medication or a defibrillator. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to safer and more effective treatments.

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

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants may have recurrent ventricular tachycardia despite antiarrhythmic medications, which suggests that some medications might be continued. Please consult with the trial coordinators for specific guidance.

What prior data suggests that this technique is safe for ventricular tachycardia?

Research has shown that pulsed field ablation (PFA) might be a safe treatment for ventricular tachycardia (VT), a type of fast heart rhythm. One study found that 88.8% of PFA treatments were successful, with no major complications or recurrence of VT. Another study reported that 11.5% of patients experienced safety issues, such as heart problems, within 180 days, though these were uncommon. PFA has also been used safely for other heart rhythm issues, suggesting it could be a viable option for VT as well. While these results are encouraging, it is important to consult a healthcare provider about potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pulse Field Ablation (PFA) for treating ventricular tachycardia because it uses a novel mechanism that differentiates it from the standard Radiofrequency Ablation (RFA) procedure. PFA targets heart tissue with electrical pulses, which can minimize damage to surrounding tissues and reduce recovery time, a clear advantage over RFA, which uses heat to achieve similar results. This precision and reduced collateral damage could mean fewer complications and a smoother recovery for patients, making PFA a promising advancement in cardiac care.

What evidence suggests that this trial's treatments could be effective for ventricular tachycardia?

This trial will compare Pulse Field Ablation (PFA) with Radiofrequency Ablation (RFA) for treating ventricular tachycardia (VT). Research has shown that PFA could effectively treat VT, a type of fast heart rhythm. In one study, PFA successfully treated VT in 85% of patients over three months without major issues. Another study found that PFA completely prevented VT from recurring in the long term. PFA targets heart tissue more accurately, helping to avoid damage to nearby areas, which may make it superior to traditional methods. While PFA is already used for other heart problems, ongoing research is examining its effectiveness specifically for VT. ^{1 2 3 4 6}

Who Is on the Research Team?

Pasquale Santangeli, MD, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with ischemic cardiomyopathy who have an ICD and experience ventricular tachycardia following a heart attack. Participants should not have had previous VT ablation and must be suitable for both PFA and RFA procedures.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

I have had a heart attack before due to blocked arteries.

Exclusion Criteria

I have the most severe form of heart failure.

I had heart surgery less than 2 months ago.

I have a low platelet count or a blood clotting disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VT ablation using either the FARAPOINT PFA catheter or the standard RFA catheters

Periprocedural

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in LVEF and new wall motion abnormalities

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Pulse Field Ablation

Trial Overview The ASCEND study compares two types of heart ablation techniques: PFA using the FARAPOINT catheter, which is new, against the standard RFA with FlexAbility SE or ThermoCool ST catheters in patients with VT due to past heart attacks.

How Is the Trial Designed?

Group I: PFA Ablation Experimental Treatment 1 Intervention

VT ablation with FARAPOINT catheter

Group II: RFA Ablation Active Control 1 Intervention

VT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Pasquale Santangeli

Lead Sponsor

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666501825004052

Pulsed field ablation for ventricular arrhythmias A multicenter study using the CENTAURI™ system (Cardiofocus, Marlborough, MA) showed an 85% success rate over 3 months without major ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.077025

High-Voltage Focal Pulsed Field Ablation to Treat Scar- ... Primary safety endpoints within 180 days occurred in 3 of 26 (11.5%) patients: cardiogenic shock, heart failure hospitalization, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11442986/

Pulsed‐Field Ablation in Management of Ventricular ... Eight (88.8%) of procedures were successful with 100% long‐term efficacy. No procedural complications or ventricular tachycardia (VT) recurrence ...

4. academic.oup.com academic.oup.com/europace/article/27/9/euaf161/8220664

Pulsed field ablation for ventricular tachycardia: are we there ... Pulsed field ablation has already shown success in atrial arrhythmias, and its tissue-specific mechanism offers theoretical advantages for VT ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00313-3/fulltext

AB-499651-002 FIRST-IN-HUMAN EVALUATION OF A ... PFA has proven to be a fast, effective, and safe modality for treating AF. However, there is little data on the utility of PFA to treat scar-related VT ...

6. hrsonline.org hrsonline.org/news/hr2025-showcases-new-advancements-emerging-paf-technology/

Heart Rhythm 2025 Showcases New Advancements in ... The Heart Rhythm Society (HRS) announced the findings of new studies demonstrating the safety and efficacy of emerging pulsed field ablation (PFA) systems.