Study of Bipolar Radio-frequency Ablation After Failed Standard Unipolar Ablation for Ventricular Arrhythmias at the Base of the Heart
Led by Centre of Postgraduate Medical Education · Updated on 2025-05-13
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying ventricular arrhythmias VA that originate at the base of the heart, focusing on cases where the standard unipolar radio-frequency RF ablation treatment fails. This study aims to find out how many patients need a follow-up procedure using bipolar RF ablation, which may be more effective for difficult-to-reach arrhythmias. They also want to identify electrophysiological signals that predict success or failure of these ablation methods and assess how these treatments affect patients quality of life.
The study involves patients who have already undergone unipolar ablation for VA but may require further treatment. If unipolar ablation does not succeed, patients may receive bipolar ablation, which uses two electrodes to deliver RF energy between adjacent heart structures for deeper tissue treatment. The procedures use advanced mapping and catheter systems to guide ablation. Patients are monitored during the procedures, and coronary angiography is performed to ensure safety. Both unipolar and bipolar ablations are evaluated for their immediate and one-month effectiveness.
Participants will have detailed heart studies and electrophysiological tests to guide treatment. They will be assessed before and after ablation with Holter ECG monitoring and quality of life questionnaires. Researchers are measuring the need for bipolar ablation after failed unipolar treatment, how well specific heart signals predict success, and the impact of ablation on symptoms and life quality over two years. Follow-up includes clinical evaluations and tests to track arrhythmia recurrence and treatment outcomes.
CONDITIONS
Brief Title
Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.
Research Team
P
Piotr Kulakowski, MD PhD
A
Agnieszka Sikorska, MD PhD
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Baseline Holter ECG within 6 months before initial unipolar ablation without antiarrhythmic drugs (beta-blockers allowed)
Initial unipolar ablation for ventricular arrhythmia originating from the base of the heart performed with detailed electrophysiological measurements
Typical indications for ablation such as more than 10,000 premature ventricular contractions in 24-hour Holter, at least 10% PVC in 24-hour Holter, symptomatic PVC, at least 3 episodes of symptomatic non-sustained ventricular tachycardia, or sustained ventricular tachycardia
Written informed consent
You will not qualify if you...
History of more than one unipolar ablation for ventricular arrhythmia originating at the base of the heart
Missing properly recorded electrophysiological parameters during baseline unipolar ablation
Lack of baseline Holter ECG performed within 6 months prior to initial unipolar ablation
Absence of typical indications for ablation
Lack of written informed consent for study participation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Initial unipolar ablation procedure followed by bipolar ablation if needed; medium-term assessment at 1 month after each ablation
Participants undergo initial unipolar ablation to treat ventricular arrhythmias originating from the base of the heart. If unipolar ablation fails, bipolar ablation is performed as a redo procedure using two ablation catheters positioned in adjacent heart structures.
1 initial ablation visit and 1 follow-up visit at 1 month; additional ablation visit if bipolar ablation is required
Follow-up
Duration - Up to 2 years
Participants are followed up to assess medium-term efficacy of ablation procedures and quality of life changes using questionnaires before and 1 month after ablation.
Periodic assessments including 24-hour Holter ECG and quality of life questionnaires before and 1 month after ablation; additional follow-up visits as needed for monitoring
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Efficacy of an Anatomical Approach in Radiofrequency Catheter Ablation of Idiopathic Ventricular Arrhythmias Originating From the Left Ventricular Outflow Tract.
Bipolar radiofrequency ablation delivered from coronary veins and adjacent endocardium for treatment of refractory left ventricular summit arrhythmias.
Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study.
Paolo Della Bella, Giovanni Peretto, Gabriele Paglino...