Actively Recruiting
Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.
Led by Centre of Postgraduate Medical Education · Updated on 2025-05-13
100
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Treatment of ventricular arrhythmias (VA) originating at the base of the heart may be challenging. Unipolar radio-frequency (RF) ablation is a standard approach to treat VA, however, it fails in 10 to 75% of patients, depending on the localization of VA. The main reason for unipolar ablation failure is the intramural location of the source of VA. In such patients, bipolar ablation may occur effective. However, there are no prospective studies or registries on consecutive patients wilt failed unipolar ablation, therefore, the proportion of candidates for bipolar ablation after failed unipolar approach is not known. Also, invasive electrophysiological parameters associated with successful unipolar and bipolar ablation have not been well established. It has been hypothesised that (1) bipolar ablation fails in 12-75% (mean 30%) of consecutive patients and these patients are candidates for bipolar ablation, (2) local ventricular signal precocity \> 20 ms, unipolar signal without R wave and pace mapping 12/12 predict effective unipolar ablation but not bipolar ablation, (3) morphology of VA from surface ECG can identify patients with possible intramural localization, and (4) successful ablation results in improvement of quality of life (QoL). Aims: 1. To assess how many patients after failed unipolar ablation need redo procedure with bipolar ablation (primary end-point) 2. To assess which intraprocedural electrophysiological parameters predict success during standard unipolar ablation (secondary endpoint) 3. To assess short term efficacy of bipolar ablation (secondary endpoint) 4. To assess one-month efficacy of bipolar ablation (secondary endpoint) 5. To assess which intraprocedural electrophysiological parameters predict success during redo bipolar ablation (secondary endpoint) 6. To evaluate the performance of ECG-based algorithms in predicting the localization / origin of VA, especially of transmural origin (secondary endpoint) 7. To assess the effects of ablation on QoL (secondary endpoint)Methods. The study group consists of all consecutive patients who underwent unipolar ablation of VA originating from the base of the heart in the Grochowski Hospital and collaborating centres. All these patients are referred to Grochowski Hospital for further follow-up and treatment if needed, including bipolar ablation if initial unipolar approach failed. In all patients acute and one-month efficacy of unipolar and bipolar ablation is assessed.
CONDITIONS
Official Title
Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baseline Holter ECG before initial unipolar ablation within 6 months prior to the procedure, performed without antiarrhythmic drugs (beta-blockers allowed).
- Initial unipolar ablation of ventricular arrhythmia originating from the base of the heart performed with detailed electrophysiological measurements and inspection of relevant heart regions.
- Typical indications for ablation include: more than 10,000 premature ventricular contractions (PVC) in 24-hour Holter ECG, or more than 10% PVC in 24-hour Holter ECG, or less frequent but symptomatic PVC, or at least 3 episodes of symptomatic non-sustained ventricular tachycardia (nsVT) in Holter ECG, or sustained ventricular tachycardia (sVT).
- Written informed consent to participate in the study.
You will not qualify if you...
- History of more than one unipolar ablation for ventricular arrhythmia originating at the base of the heart.
- Lack of properly acquired electrophysiological parameters during baseline unipolar ablation.
- No baseline Holter ECG performed within 6 months prior to initial unipolar ablation.
- Absence of typical indication for ablation.
- Lack of written informed consent for participation in the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland, 04-073
Actively Recruiting
Research Team
P
Piotr Kulakowski, MD PhD
CONTACT
A
Agnieszka Sikorska, MD PhD
CONTACT
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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