Bipolar ablation for treating ventricular arrhythmias after unipolar failure

Bipolar Radio-frequency Ablation After Standard Unipolar Approach for Ventricular Arrhythmias Originating From the Base of the Heart. The BiUniVA Prospective Registry

This study is testing if a new type of heart procedure called bipolar ablation can help patients with heart rhythm problems who didn't get better from an earlier treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre of Postgraduate Medical Education (Academic / other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT05707637 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of bipolar radio-frequency ablation in patients who have previously undergone unipolar ablation for ventricular arrhythmias originating from the base of the heart. It seeks to establish the proportion of patients who may benefit from bipolar ablation after unipolar failure and to identify invasive electrophysiological parameters associated with successful outcomes. The study will involve detailed measurements of electrophysiological parameters and will include patients who meet specific criteria related to their arrhythmia history and prior treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have experienced failed unipolar ablation for ventricular arrhythmias originating from the base of the heart.

Not a fit: Patients who have not undergone unipolar ablation or those with arrhythmias not originating from the base of the heart may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with ventricular arrhythmias that are difficult to treat with standard unipolar ablation.

How similar studies have performed: There is currently a lack of prospective studies on bipolar ablation following failed unipolar ablation, making this approach relatively novel.

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

Where this trial is running

Warsaw

• Department of Cardiology, Postgraduate Medical School, Grochowski Hospital — Warsaw, Poland (Recruiting)

Study contacts

• Principal investigator: Piotr Kulakowski, MD PhD — Centre for Medical Postgraduate Education
• Study coordinator: Piotr Kulakowski, MD PhD

Conditions Ventricular Arrythmia; ventricular arrhythmia; unipolar ablation; bipolar ablation; base of the heart