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

Launched by CENTRE OF POSTGRADUATE MEDICAL EDUCATION · Jan 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called bipolar radio-frequency ablation for patients who have ventricular arrhythmias, which are irregular heartbeats that can start at the base of the heart. Sometimes, a standard treatment called unipolar ablation does not work, and this trial aims to find out how many patients might need a second procedure with bipolar ablation after an unsuccessful unipolar attempt. The researchers also want to learn which specific heart signals can predict the success of both types of ablation and how these treatments can improve patients’ quality of life.

To be eligible for this trial, participants must be between the ages of 65 and 74 and have previously undergone unipolar ablation for their heart condition, with specific criteria met beforehand. Participants can expect thorough evaluations of their heart signals before and after the procedures and will be closely monitored for at least a month to assess how well the treatments work. If you or a loved one is considering joining this study, it’s important to discuss any questions with your healthcare provider to understand the potential benefits and risks involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Baseline Holter ECG before initial unipolar ablation within 6 months prior to the procedure, performed without antiarrhythmic drugs (beta-blockers allowed).
• • 2. Initial unipolar ablation of VA originating from the base of the heart (R in II, III and aVF) performed according to the standard scheme which includes detailed measurements of EP parameters at each examined and/or ablated site and inspection of all three regions (RVOT with PA, GCV and LVOT/AoCusps/AMC/MA) in cases with unsatisfactory EP parameters or failed ablation at first or second site.
• • 3. Typical indications for ablation: a. \> 10 000 PVC in 24-hour Holter ECG or b. \> 10% PVC in 24-hour Holter ECG or c. less frequent but symptomatic PVC or d. at least 3 episodes symptomatic non-sustained ventricular tachycardia (nsVT) (\>3 QRS evolutions) in Holter ECG, regardless of the amount of PVC or e. sustained ventricular tachycardia (sVT), regardless of nsVT or PVC
• • 4. Written informed consent
• Exclusion Criteria:
• • 1. History of \> 1 unipolar ablation for VA originating at the base of the heart
• • 2. Lack of properly acquired EP parameters during baseline unipolar ablation
• • 3. Lack of baseline Holter ECG performed \< 6 months prior to initial unipolar ablation
• • 4. Absence of typical indication for ablation
• • 5. Lack of written informed consent for participation in the study