Bipolar ablation for treating ventricular arrhythmias after unipolar failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: piotr.kulakowskimd@gmail.com
• Phone: 604455081

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.