Ventricular TachycardiaASCEND-VTNCT06891456
Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
A study testing RFA Ablation and PFA Ablation in people with Ventricular Tachycardia and Ischemic Heart Disease, run by Pasquale Santangeli at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Heart Disease, Sustained VT
- What is being tested?
- RFA Ablation and PFA Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
- Comorbidity likely to limit survival to <12 months
- New York Heart Association class IV heart failure.
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- Estimated glomerular filtration rate <30 ml/min/1.73m2.
- Thrombocytopenia or coagulopathy.
- Contraindication to heparin.
- Pregnancy or lactation.
- Cardiac surgery within the past 2 months.
- Active infection.
- Clinical, laboratory or imaging evidence of active ischemia.
- Severe left heart valvular heart disease (aortic/mitral stenosis or regurgitation).
- Any concomitant congenital heart disease.
- Prior catheter or surgical ablation of VT within the past 2 months.
- Anticipated need for epicardial mapping and ablation.
- For individuals with no pre-existing ICD: Ineligibility for an ICD implant.
- Pre-existing LVAD or other hemodynamic assist device
- Present mechanical heart valve
- cardiogenic shock unless it is due to incessant VT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Pasquale Santangeli, MD, PhD, 216-445-1940, santanp3@ccf.org
Yuki Kuramochi, BSN, RN, 216-445-4063, kuramoy@ccf.org
About this study
Official title: Pulse Field Ablation for Post-Infarction Ventricular Tachycardia: the ASCEND Pilot Study
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.
Read the 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.
- Being tested
- RFA Ablation, PFA Ablation
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA AblationDevice
RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
PFA AblationDevice
PFA ablation of VT substrate using FARAPOINT catheter
| Study group | Role | What they receive |
|---|---|---|
| RFA Ablation | Active comparator | VT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters Receives: Device: RFA Ablation |
| PFA Ablation | Experimental | VT ablation with FARAPOINT catheter Receives: Device: PFA Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Efficiency
Total ablation time (in seconds) needed to achieve complete elimination of late abnormal ventricular activities (LAVAs) in myocardial scar.
Measured: Periprocedural
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
Measured: Within 7 days post procedure
Secondary outcomes (1)
Secondary Safety
Changes in LVEF and/or new wall motion abnormalities at follow-up TTE
Measured: 180 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start16 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pasquale Santangeli
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Pasquale Santangeli, The Cleveland Clinic
- Investigators
- Pasquale Santangeli, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891456
- Sponsor's protocol ID
- G250026
- Acronym
- ASCEND-VT
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Field Ablation for Post-Infarction Ventricular Tachycardia: the ASCEND Pilot Study
- ClinicalTrials.gov ID
- NCT06891456
- Acronym / sponsor ID
- ASCEND-VT / G250026
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pasquale SantangeliUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA Ablation | Active comparator | Device: RFA AblationVT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters |
| PFA Ablation | Experimental | Device: PFA AblationVT ablation with FARAPOINT catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
- Comorbidity likely to limit survival to <12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFA AblationRFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter | Device | RFA Ablation |
| PFA AblationPFA ablation of VT substrate using FARAPOINT catheter | Device | PFA Ablation |
Primary outcome
Procedural Efficiency
Time frame: Periprocedural
Total ablation time (in seconds) needed to achieve complete elimination of late abnormal ventricular activities (LAVAs) in myocardial scar.
Procedural Safety
Time frame: 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
1 secondary outcome
Secondary Safety
Time frame: 180 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pasquale Santangeli, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA Ablation and PFA Ablation in people with Ventricular Tachycardia and Ischemic Heart Disease, run by Pasquale Santangeli at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pasquale Santangeli, MD, PhD (216-445-1940, santanp3@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Efficiency (time frame: Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.