Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.

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.

NCT Number	NCT05707637
Lead Sponsor	Centre of Postgraduate Medical Education
Conditions	Ventricular Arrythmia
Enrollment	100 participants
Start Date	2022-11-02
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-13