Pulse Field Ablation for Post-Infarction Ventricular Tachycardia (ASCEND)

NeuroTherapia, Inc.

Status: Begins enrollment in 1 month

Conditions: Ischemic Heart Disease; Sustained VT; Ventricular Tachycardia

Treatments: Device: PFA Ablation; Device: RFA Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06891456

G250026

Details and patient eligibility

About

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.

Full 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 RFA).

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 RFA catheters).

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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. allergy to radiographic contrast dye
22. cardiogenic shock unless it is due to incessant VT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

RFA Ablation

Active Comparator group

Description:

VT ablation with FlexAbility or ThermoCool ST catheter

Treatment:

Device: RFA Ablation

PFA Ablation

Experimental group

Description:

VT ablation with FARAPOINT cather

Treatment:

Device: PFA Ablation