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New treatment option for Ventricular Tachycardia
Official title Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
ClinicalTrials.gov ID: NCT06891456
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- any of the following:
- 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
See the full eligibility 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:
- ≥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.
- any of the following:
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.