Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
NCT ID: NCT06891456
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-16
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RFA Ablation
VT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters
RFA Ablation
RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
PFA Ablation
VT ablation with FARAPOINT catheter
PFA Ablation
PFA ablation of VT substrate using FARAPOINT catheter
Interventions
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RFA Ablation
RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
PFA Ablation
PFA ablation of VT substrate using FARAPOINT catheter
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Pasquale Santangeli
OTHER
Responsible Party
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Pasquale Santangeli
Sponsor-Investigator
Principal Investigators
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Pasquale Santangeli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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G250026
Identifier Type: -
Identifier Source: org_study_id
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