Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPasquale Santangeli
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years.
Ischemic heart disease with prior myocardial infarction.
Left ventricular ejection fraction ≥20% estimated by transthoracic echocardiography (TTE) within 90 days prior to enrollment.
≥2documented episodes in patients with implantable cardioverter defibrillators (ICD)
Disqualifiers
Unable to provide informed consent.
Idiopathic VT.
Mobile LV thrombus.
Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment).
Trial design
Treatments tested in this trial
- RFA Ablation
- PFA Ablation
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pasquale Santangeli
Lead sponsor
The Cleveland Clinic
Sponsor institution
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov