Pulse Field Ablation for Post-Infarction Ventricular Tachycardia

Description

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.

Conditions

Ventricular Tachycardia, Ischemic Heart Disease, Sustained VT

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Study Overview

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Study Details

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 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.

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

Pulse Field Ablation for Post-Infarction Ventricular Tachycardia

Condition
Ventricular Tachycardia
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Pasquale Santangeli, MD, PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2028-12-31