Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia (ASCEND-VT)

Pulse Field Ablation for Post-Infarction Ventricular Tachycardia: the ASCEND Pilot Study

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 ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SE 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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease; Ventricular Tachycardia; Sustained VT
• Intervention / Treatment: Device: RFA Ablation; Device: PFA Ablation

Detailed Description

The ASCEND trial is a pilot study that will test the hypothesis that the novel FARAPOINT catheter and the FARAPULSE PFA platform can accomplish ischemic substrate VT ablation more efficiently and with a similar safety profile compared to a contemporary, widely adopted RFA technology (ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SE).

ASCEND is a single center, controlled (two-arm), 1:1 parallel-randomized, open-label pilot study of 40 consecutively enrolled patients with ischemic cardiomyopathy and drug refractory or drug intolerant VT in whom a catheter ablation procedure is indicated. The study intervention consists of the use of a novel FARAPOINT PFA catheter during the entire VT ablation procedure. Patients randomized to the control arm of the study will undergo VT ablation using a contemporary standard-of-care technology (ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SEcatheters).

This pilot study is designed to test for superiority with respect to the primary efficacy metric and to ensure comparable safety profiles of both ablation methods.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuki Kuramochi, BSN, RN; Phone Number: 216-445-4063; Email: kuramoy@ccf.org
• Study Contact Backup: Name: Pasquale Santangeli, MD, PhD; Phone Number: 216-445-1940; Email: santanp3@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Yuki Kuramochi, BSN, RN; Phone Number: 216-445-4063; Email: kuramoy@ccf.org
      • Contact: Pasquale Santangeli, MD, PhD; Phone Number: 216-445-1940; Email: santanp3@ccf.org
      • Sub-Investigator: Jakub Sroubek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: must meet all of the following:

1. Age ≥18 years.
2. Ischemic heart disease with prior myocardial infarction.
3. Left ventricular ejection fraction ≥20% estimated by transthoracic echocardiography (TTE) within 90 days prior to enrollment.

4. Documented sustained monomorphic VT with any of the following characteristics:

   1. ≥2documented episodes in patients with implantable cardioverter defibrillators (ICD)
   2. ≥1 documented episode(s) in patients without ICD
   3. Recurrent VT despite antiarrhythmic medications (ineffective, contraindicated or not tolerated) or ICD interventions
5. Provision of signed and dated informed consent form.
6. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria: any of the following:

1. Unable to provide informed consent.
2. Idiopathic VT.
3. Mobile LV thrombus.
4. Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment).
5. Comorbidity likely to limit survival to <12 months
6. New York Heart Association class IV heart failure.
7. Estimated glomerular filtration rate <30 ml/min/1.73m2.
8. Thrombocytopenia or coagulopathy.
9. Contraindication to heparin.
10. Pregnancy or lactation.
11. Cardiac surgery within the past 2 months.
12. Active infection.
13. Clinical, laboratory or imaging evidence of active ischemia.
14. Severe left heart valvular heart disease (aortic/mitral stenosis or regurgitation).
15. Any concomitant congenital heart disease.
16. Prior catheter or surgical ablation of VT within the past 2 months.
17. Anticipated need for epicardial mapping and ablation.
18. For individuals with no pre-existing ICD: Ineligibility for an ICD implant.
19. Pre-existing LVAD or other hemodynamic assist device
20. Present mechanical heart valve
21. cardiogenic shock unless it is due to incessant VT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RFA Ablation; VT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters	Device: RFA Ablation; RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
Experimental: PFA Ablation; VT ablation with FARAPOINT catheter	Device: PFA Ablation; PFA ablation of VT substrate using FARAPOINT catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Efficiency	Total ablation time (in seconds) needed to achieve complete elimination of late abnormal ventricular activities (LAVAs) in myocardial scar.	Periprocedural
Procedural Safety	Count of individuals who experience any of the following: Cardiac perforation; Pericardial effusion with hemodynamic compromise or needing intervention; New complete heart block; Coronary spasm; Acute MI; New acute severe mitral regurgitation or aortic regurgitation; Deep venous thrombosis; Vascular injury requiring surgical or percutaneous intervention; Pulmonary embolism; Stroke; Acute kidney injury; Death	Within 7 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety	Changes in LVEF and/or new wall motion abnormalities at follow-up TTE	180 days post procedure

Collaborators and Investigators

• Sponsor: Pasquale Santangeli
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Pasquale Santangeli, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Arrhythmias, Cardiac; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Infarction; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: G250026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes