Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Pasquale Santangeli
Study ID
NCT06891456
Status
Recruiting
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Conditions

  • Ischemic Heart Disease
  • Sustained VT
  • Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 16, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: RFA Ablation
    VT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters
  • Experimental: PFA Ablation
    VT ablation with FARAPOINT catheter

Primary Outcome Measure

Procedural Efficiency [ Time Frame: Periprocedural ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Pasquale Santangeli, MD, PhD
[email protected]
216-445-1940
Yuki Kuramochi, BSN, RN
[email protected]
216-445-4063
Jakub Sroubek, MD (SUB_INVESTIGATOR)

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