AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

RecruitingNAAges 18 Years - anyAllPasquale Santangeli
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: must meet all of the following: 1. Age โ‰ฅ18 years. 2. Ischemic heart disease with prior myocardial infarction. 3. Left ventricular ejection fraction โ‰ฅ20% estimated by transthoracic echocardiography (TTE) within 90 days prior to enrollment. 4. Documented sustained monomorphic VT with any of the following characteristics: 1. โ‰ฅ2documented episodes in patients with implantable cardioverter defibrillators (ICD) 2. โ‰ฅ1 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 โ‰ฅ1 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
๐Ÿ’Š

What it tests

  • RFA Ablation
  • PFA Ablation
๐Ÿ“

Where

1 site
Cleveland Clinic
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy