Pulsed field ablation versus radiofrequency for ventricular tachycardia after a heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ASCEND is a single-center, randomized, open-label pilot comparing a novel FARAPOINT pulsed field ablation (PFA) catheter with contemporary radiofrequency (RFA) catheters for ischemic substrate ventricular tachycardia (VT) ablation. Forty patients with ischemic cardiomyopathy and drug-refractory or drug-intolerant sustained monomorphic VT will be randomized 1:1 to PFA or RFA and treated at the Cleveland Clinic. The study is designed to test for superiority on a primary efficacy metric while ensuring comparable safety profiles between arms. Procedures use the FARAPOINT/FARAPULSE platform for PFA versus ThermoCool/FlexAbility/TactiFlex family catheters for standard RFA.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Pasquale Santangeli, MD, PhD — The Cleveland Clinic
• Study coordinator: Pasquale Santangeli, MD, PhD
• Email: santanp3@ccf.org
• Phone: 216-445-1940

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.