Actively Recruiting
Evaluation of Dual Energy THERMOCOOL SMARTTOUCH SF Catheter with TRUPULSE Generator for Treating Ventricular Arrhythmias Using a Specific Procedural Workflow
Led by Biosense Webster, Inc. · Updated on 2026-08-10
90
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Dual Energy THERMOCOOL SMARTTOUCH SF catheter combined with the TRUPULSE generator for treating ventricular arrhythmias. This study focuses on whether the abnormal heart rhythms, including premature ventricular complexes and sustained monomorphic ventricular tachycardias, can be successfully treated using a specific procedural workflow during cardiac ablation. The trial also monitors participant safety by checking for any complications after the procedure. Participants undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator, which delivers radiofrequency and pulsed field energy mainly as RFPF stacking applications according to the studys procedural workflow. The study groups include those being treated for premature ventricular complexes and different types of sustained ventricular tachycardia. The study tracks the procedures effectiveness and safety over several months following the ablation. During the study, participants are monitored with assessments including electrocardiographic data review, tracking of adverse events up to six months post-procedure, and intraoperative measurements such as procedure time, mapping details, and ablation parameters. Researchers measure the success of the procedural workflow at 3 months for premature ventricular complexes and at 6 months for ventricular tachycardia cases. Safety is closely observed up to 7 days and 6 months after the ablation to detect any adverse effects or complications.
CONDITIONS
Brief Title
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned catheter ablation for premature ventricular complexes or sustained monomorphic ventricular tachycardia
- Age 18 years or older
- Willing and able to provide consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- For sustained monomorphic ventricular tachycardia cases, an implantable cardioverter defibrillator (ICD) is already implanted or planned during the same hospital admission
You will not qualify if you...
- Incessant ventricular arrhythmia requiring hemodynamic support before ablation
- Polymorphic ventricular tachycardia, unstable ventricular tachycardia, or ventricular fibrillation
- Idiopathic ventricular tachycardias
- Suspected reversible causes of ventricular arrhythmia (e.g., electrolyte imbalance, thyroid disease, drug-induced arrhythmia)
- Ventricular arrhythmias from channelopathies
- Severely reduced left ventricular ejection fraction (<20%)
- Uncontrolled heart failure or New York Heart Association Class IV
- Unsafe pre-procedure stimulation protocol at screening
- Recent percutaneous coronary intervention or myocardial infarction within 2 months
- Unstable angina within past 6 months
- Intracardiac thrombus on pre-ablation imaging
- Conditions preventing vascular access (e.g., inferior vena cava filter)
- Planned epicardial mapping or ablation before index ablation
- History of blood clotting or bleeding disorders or contraindication to anticoagulation
- Contraindication to contrast agents
- Life expectancy less than 6 months due to advanced illness
- Planned major surgery or cardiac transplantation within 6 months
- Previous ventricular arrhythmia ablation within 6 months
- Pregnant, lactating, or women planning pregnancy during the study
- Significant congenital anomaly or medical condition precluding enrollment
- Contraindications for devices used in the study
- Recent ventriculotomy or atriotomy within 8 weeks
- Presence of cardiac tumors or abnormalities preventing catheter use
- Prosthetic heart valves
- Acute illness, infection, or sepsis
- Current enrollment in another investigational study
- Classified as vulnerable population requiring special safeguards
Research Team
K
Katie Steenackers, MD
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