Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry. - Trial NCT05707637

Timeline & Enrollment

Primary Outcome

Candidates for redo bipolar ablation

Summary

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.

ICD-10 Classifications