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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA Ablation | Active Comparator | VT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters |
|
| PFA Ablation | Experimental | VT ablation with FARAPOINT catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFA Ablation | Device | RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Efficiency | Total ablation time (in seconds) needed to achieve complete elimination of late abnormal ventricular activities (LAVAs) in myocardial scar. | Periprocedural |
| Procedural Safety | Count of individuals who experience any of the following:
| Within 7 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety | Changes in LVEF and/or new wall motion abnormalities at follow-up TTE | 180 days post procedure |
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Inclusion Criteria: must meet all of the following:
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:
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria: any of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pasquale Santangeli, MD, PhD | Contact | 216-445-1940 | santanp3@ccf.org | |
| Yuki Kuramochi, BSN, RN | Contact | 216-445-4063 | kuramoy@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Pasquale Santangeli, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| PFA Ablation | Device | PFA ablation of VT substrate using FARAPOINT catheter |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |