Health TrialsbyHealthPanel

Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

ConditionsVentricular TachycardiaIschemic Heart DiseaseSustained VT
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • RFA Ablation

    Device

    RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter

  • PFA Ablation

    Device

    PFA ablation of VT substrate using FARAPOINT catheter

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: RFA AblationActive comparator 1 intervention
Group B: PFA AblationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Procedural Efficiency

Total ablation time (in seconds) needed to achieve complete elimination of late abnormal ventricular activities (LAVAs) in myocardial scar.

Time frame
Periprocedural
2

Procedural Safety

Count of individuals who experience any of the following: * Cardiac perforation * Pericardial effusion with hemodynamic compromise or needing intervention * New complete heart block * Coronary spasm * Acute MI * New acute severe mitral regurgitation or aortic regurgitation * Deep venous thrombosis * Vascular injury requiring surgical or percutaneous intervention * Pulmonary embolism * Stroke * Acute kidney injury * Death

Time frame
Within 7 days post procedure

Secondary outcomes

1

Secondary Safety

Changes in LVEF and/or new wall motion abnormalities at follow-up TTE

Time frame
180 days post procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pasquale Santangeli

Lead sponsor

The Cleveland Clinic

Sponsor institution

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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