Recruiting

PFA vs. RFA

Sponsor:

Pasquale Santangeli

Code:

NCT06891456

Conditions

Ventricular Tachycardia

Ischemic Heart Disease

Sustained VT

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RFA Ablation

PFA Ablation

Study Details

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

Study ID

NCT06891456

Start date

Jun 16, 2025

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: RFA Ablation

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

experimental: PFA Ablation

VT ablation with FARAPOINT catheter

Interventions

RFA Ablation

RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter

PFA Ablation

PFA ablation of VT substrate using FARAPOINT catheter

Primary outcome measure

  • Procedural Efficiency [ Time Frame: Periprocedural ]
  • Procedural Safety [ Time Frame: Within 7 days post procedure ]

Central Contacts and Locations

Central contacts

Pasquale Santangeli, MD, PhD

216-445-1940santanp3@ccf.org

Yuki Kuramochi, BSN, RN

216-445-4063kuramoy@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Pasquale Santangeli, MD, PhD

216-445-1940santanp3@ccf.org

Yuki Kuramochi, BSN, RN

216-445-4063kuramoy@ccf.org

More Information

Sponsor

Pasquale Santangeli

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pasquale Santangeli on 2026-09-03.