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Recruiting NCT06891456

Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

No phase Interventional Ventricular Tachycardia Ischemic Heart Disease Sustained VT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RFA Ablation, PFA Ablation.
Who it may be relevant to
Registry conditions: Ventricular Tachycardia, Ischemic Heart Disease, Sustained VT. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Device RFA Ablation
    RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
  • Device PFA Ablation
    PFA ablation of VT substrate using FARAPOINT catheter

Primary outcome measures

  • Procedural Efficiency [Time frame: Periprocedural]
  • Procedural Safety [Time frame: Within 7 days post procedure]
Secondary outcome measures (1)
  • Secondary Safety [Time frame: 180 days post procedure]

Eligibility criteria

Inclusion Criteria: must meet all of the following:

  • 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.

Exclusion Criteria: any of the following:

  • 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.
  • Prior catheter or surgical ablation of VT within the past 2 months.
  • Anticipated need for epicardial mapping and ablation.
  • For individuals with no pre-existing ICD: Ineligibility for an ICD implant.
  • Pre-existing LVAD or other hemodynamic assist device
  • Present mechanical heart valve
  • cardiogenic shock unless it is due to incessant VT

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06891456 · G250026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗