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New treatment option for Refractory Ventricular Tachycardia
Official title Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
ClinicalTrials.gov ID: NCT05337241
What this study is testing
- What it's testing
- The Thermedical Ablation System and Durablate catheter is indicated for use in patients with recurrent, sustained, monomorphic ventricular tachycardia (SMVT) refractory to drug therapy and conventional (approved) catheter ablation. Subjects with recurrent, SMVT refractory to drug therapy and conventional catheter ablation who are not eligible for, or will not likely benefit from repeat endocardial ablation using an approved catheter.
- 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
- Subject has structural heart disease
- Subject has recurrent symptomatic sustained (\> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study...
- At least 3 episodes of the MMVT have been treated with ATP and/or shock, OR at least 2 episodes were treated with shock AND
- Documentation of the presumed recurrent MMVT was treated with prior catheter ablation AND
- Occurred despite treatment with at least one Class III antiarrhythmic after last ablation or treatment with a Class III antiarrhythmic is not...
You likely can't join if
- Idiopathic VT (VT occurring in people without structural heart disease [including the absence of LGE on MRI, if performed], metabolic abnormalities...
- Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum
- Subject with a prior ablation within 4 weeks of planned study ablation
- Subject's VT is not amenable to treatment with the study device at the time of mapping for the study ablation
- Only PVCs are induced during mapping for the study ablation
- No clinical VT induced during mapping for the study ablation
See the full eligibility criteria
Who can join
- Subject has structural heart disease
- Subject has recurrent symptomatic sustained (\> 30 seconds) monomorphic ventricular tachycardia (MMVT) within 180 days prior to planned study ablation that meets the following criteria:
- At least 3 episodes of the MMVT have been treated with ATP and/or shock, OR at least 2 episodes were treated with shock AND
- Documentation of the presumed recurrent MMVT was treated with prior catheter ablation AND
- Occurred despite treatment with at least one Class III antiarrhythmic after last ablation or treatment with a Class III antiarrhythmic is not tolerated or is contraindicated AND
- VT has recurred despite VT ablation at one of the investigational centers UORU the investigator documents the reason that the subject is unlikely to benefit from a repeat ablation using a conventional, approved catheter.
- Subject is at least 18 years old
- Subject has an implantable cardioverter-defibrillator (ICD) with a full 6-month (prior to planned study ablation) ICD interrogation history documenting incidences of VT
- Subject is able to provide informed consent
What rules you out
- Idiopathic VT (VT occurring in people without structural heart disease [including the absence of LGE on MRI, if performed], metabolic abnormalities or long QT syndrome)
- Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum
- Subject with a prior ablation within 4 weeks of planned study ablation
- Subject's VT is not amenable to treatment with the study device at the time of mapping for the study ablation
- Only PVCs are induced during mapping for the study ablation
- No clinical VT induced during mapping for the study ablation
- Planned use of a non-study ablation catheter
- Subject has an LVEF \< 20% reported on pre-ablation imaging (CT, MRI or echocardiogram within 48 hours of the study procedure)
- Subject with evidence of any right- or left-sided (including left atrium, left atrial appendage and left ventricle) intracardiac thrombus OR pericardial effusion (except chronic trivial) reported on required...
- people with atrial fibrillation/flutter (paroxysmal, persistent, or permanent) without uninterrupted anticoagulation for at least 3 weeks immediately prior to the date of ablation procedure. (Interruption of...
- people with NYHA Class IV heart failure
- Renal dysfunction with eGFR \<30 ml/min/1.73mP2
- Subject with known coagulopathy or other condition likely to increase risk of periprocedural bleeding
- Subject with known coagulopathy or other condition likely to increase risk of a thrombotic event
- Subject with a mechanical aortic valve, mechanical mitral valve, or MitraClip
- Subject with flail mitral leaflet or severe aortic stenosis
- Subject with LAA occlusion device
- Subject with a congenital heart defect except patent foramen ovale (PFO)
- Subject with suspected life expectancy of less than 1 year
- Subject with myocardial infarction (MI) or unstable angina (UA) within previous 90 days
- Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 90 days
- Subject with known untreated significant ischemic coronary artery disease, acute illness (unrelated to VT or its origin) or active systemic infection.
- Subject with left ventricular assist device planned or required for the procedure
- Females who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test)
- Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention including heparin and ionic contrast media
- Contraindication to cardiac CT
- Subject concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results
- Subject with a condition (including a chronic illness) or circumstance that the investigator feels puts the subject at an unacceptable risk for participation in the study or may interfere with quality data collection or...
- Subject is not willing or is unable to participate in all study procedures and follow-up requirements \-
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
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 Birmingham, Alabama, United States; Philadelphia, Pennsylvania, United States; Charleston, South Carolina, United States; Nashville, Tennessee, United States; Salt Lake City, Utah, United States; Montreal, Quebec, Canada and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.