Pulse Field Ablation for Ventricular Tachycardia

(ASCEND 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

Trial Summary

What is the purpose of this trial?

ASCEND is a randomized controlled open-label pilot study evaluating the safety and effectiveness of pulsed field ablation (PFA) with the novel FARAPOINT catheter compared to the standard radiofrequency (RFA) ablation with FlexAbility SE or ThermoCool ST catheter for ablation of ventricular tachycardia (VT) in the patients with ischemic cardiomyopathy and implantable cardioverter-defibrillator (ICD). The study hypothesis is that the PFA ablation is more efficient compared to the RFA technique but retains a comparable safety profile.

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 data supports the effectiveness of the treatment Pulse Field Ablation for Ventricular Tachycardia?

While there is no direct data on Pulse Field Ablation for Ventricular Tachycardia, catheter ablation, a similar treatment, has shown benefits as a first-line therapy for patients with certain heart conditions, suggesting that ablation techniques can be effective in managing ventricular tachycardia. ^{1 2 3 4 5}

Is Pulse Field Ablation generally safe for humans?

A case series reported on the use of Pulse Field Ablation for ventricular tachycardia, noting that it is well-tolerated and can be applied quickly, but did not specifically mention any safety concerns. ^{6 7 8 9 10}

How does Pulse Field Ablation treatment for ventricular tachycardia differ from other treatments?

Pulse Field Ablation is unique because it relies on proximity rather than direct contact, making it useful in areas with poor stability. It allows for fast application and can treat large areas of the heart's inner lining quickly and with minimal impact on blood flow, unlike traditional methods that may require more precise contact and longer application times. ^{7 11 12 13 14}

Research Team

Pasquale Santangeli, MD, PhD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: PFA Ablation Experimental Treatment 1 Intervention

VT ablation with FARAPOINT cather

Group II: RFA Ablation Active Control 1 Intervention

VT ablation with FlexAbility or ThermoCool ST catheter

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

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

Findings from Research

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]

References

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

Catheter Ablation of Ventricular Tachycardia as the First-Line Therapy in Patients With Coronary Artery Disease and Preserved Left Ventricular Systolic Function: Long-Term Results. [2022]

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

Role of implantable cardioverter defibrillator therapy in the management of high-risk patients. [2006]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Ventricular tachycardia: a hospital perspective. [2005]

4. Australia pubmed.ncbi.nlm.nih.gov

Male sex increases mortality in ventricular tachyarrhythmias. [2020]

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

Catheter ablation of ventricular tachycardia in nonischemic heart disease. [2012]

6. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. [2023]

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

Case Series of Ventricular Tachycardia Ablation With Pulsed-Field Ablation: Pushing Technology Further (Into the Ventricle). [2023]

8. England pubmed.ncbi.nlm.nih.gov

A decade of catheter ablation of cardiac arrhythmias in Sweden: ablation practices and outcomes. [2020]

9. Italy pubmed.ncbi.nlm.nih.gov

[Comparative study of results of catheter ablation in ventricular tachycardia of different etiologies]. [2007]

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

Risk of radiation induced skin injuries from arrhythmia ablation procedures. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Intraventricular electrogram mapping and radiofrequency cardiac ablation for ventricular tachycardia. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

[Ventricular tachycardia ablation guided by LocaLisa system in patients with structural heart disease]. [2006]

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

Catheter ablation for control of ventricular tachycardia: a report of the percutaneous cardiac mapping and ablation registry. [2019]

14. Hungary pubmed.ncbi.nlm.nih.gov

[Catheter ablation of ventricular tachycardias]. [2015]