Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

NCT06891456 | Recruiting DMC FDA Device

• 1 other identifier: G250026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia; Ischemic Heart Disease; Sustained VT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary Safety

  180 days post procedure

Study Arms (2)

RFA Ablation

ACTIVE COMPARATOR

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

Device: RFA Ablation

PFA Ablation

EXPERIMENTAL

VT ablation with FARAPOINT catheter

Device: PFA Ablation

Interventions

RFA Ablation DEVICE

RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter

RFA Ablation

PFA Ablation DEVICE

PFA ablation of VT substrate using FARAPOINT catheter

PFA Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Ischemic heart disease with prior myocardial infarction.
• Left ventricular ejection fraction ≥20% estimated by transthoracic echocardiography (TTE) within 90 days prior to enrollment.
• Documented sustained monomorphic VT with any of the following characteristics:
• ≥2documented episodes in patients with implantable cardioverter defibrillators (ICD)
• ≥1 documented episode(s) in patients without ICD
• Recurrent VT despite antiarrhythmic medications (ineffective, contraindicated or not tolerated) or ICD interventions
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if:

• Unable to provide informed consent.
• Idiopathic VT.
• Mobile LV thrombus.
• Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment).
• Comorbidity likely to limit survival to \<12 months
• New York Heart Association class IV heart failure.
• Estimated glomerular filtration rate \<30 ml/min/1.73m2.
• Thrombocytopenia or coagulopathy.
• Contraindication to heparin.
• Pregnancy or lactation.
• Cardiac surgery within the past 2 months.
• Active infection.
• Clinical, laboratory or imaging evidence of active ischemia.
• Severe left heart valvular heart disease (aortic/mitral stenosis or regurgitation).
• Any concomitant congenital heart disease.

Sponsors & Collaborators

• Pasquale Santangeli: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Pasquale Santangeli, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pasquale Santangeli, MD, PhD

CONTACT

216-445-1940; santanp3@ccf.org

Yuki Kuramochi, BSN, RN

CONTACT

216-445-4063; kuramoy@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)