Ischemic Heart Disease, Sustained VT, Ventricular Tachycardia
Conditions
Brief 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.
Detailed description
The ASCEND trial is a pilot study that will test the hypothesis that the novel FARAPOINT catheter and the FARAPULSE PFA platform can accomplish ischemic substrate VT ablation more efficiently and with a similar safety profile compared to a contemporary, widely adopted RFA technology (ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SE). 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.
Interventions
DEVICERFA Ablation
RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
DEVICEPFA Ablation
PFA ablation of VT substrate using FARAPOINT catheter
Sponsors
Pasquale Santangeli
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
must meet all of the following: 1. Age ≥18 years. 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
any of the following: 1. Unable to provide informed consent. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Efficiency | Periprocedural | Total ablation time (in seconds) needed to achieve complete elimination of late abnormal ventricular activities (LAVAs) in myocardial scar. |
| Procedural Safety | Within 7 days post procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety | 180 days post procedure | Changes in LVEF and/or new wall motion abnormalities at follow-up TTE |
Countries
United States
Contacts
CONTACTPasquale Santangeli, MD, PhD
CONTACTYuki Kuramochi, BSN, RN
PRINCIPAL_INVESTIGATORPasquale Santangeli, MD, PhD
The Cleveland Clinic
Outcome results
None listed