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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Documented sustained monomorphic VT with any of the following characteristics:

‣ ≥2documented episodes in patients with implantable cardioverter defibrillators (ICD)

⁃ ≥1 documented episode(s) in patients without ICD

⁃ Recurrent VT despite antiarrhythmic medications (ineffective, contraindicated or not tolerated) or ICD interventions

• Provision of signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Pasquale Santangeli, MD, PhD
santanp3@ccf.org
216-445-1940
Backup
Yuki Kuramochi, BSN, RN
kuramoy@ccf.org
216-445-4063
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 40
Treatments
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
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Pasquale Santangeli

This content was sourced from clinicaltrials.gov