RECRUITING

Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

Conditions

Ventricular Tachycardia Ischemic Heart Disease Sustained VT

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Study Overview

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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 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.

Official Title

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

Quick Facts

Study Start:2025-06-16

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06891456

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. cardiogenic shock unless it is due to incessant VT

Inclusion Criteria

Exclusion 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. cardiogenic shock unless it is due to incessant VT

Contacts and Locations

Study Contact

Pasquale Santangeli, MD, PhD

CONTACT

216-445-1940

santanp3@ccf.org

Yuki Kuramochi, BSN, RN

CONTACT

216-445-4063

kuramoy@ccf.org

Principal Investigator

Pasquale Santangeli, MD, PhD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Pasquale Santangeli

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-16

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-06-16

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Ventricular Tachycardia
Ischemic Heart Disease
Sustained VT