NCT05707637 Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.
| NCT ID | NCT05707637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre of Postgraduate Medical Education |
| Condition | Ventricular Arrythmia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-11-02 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-11-02 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Piotr Kulakowski, MD PhD
PRINCIPAL INVESTIGATOR
Centre for Medical Postgraduate Education
Frequently Asked Questions
Who can join the NCT05707637 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Arrythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05707637 currently recruiting?
Yes, NCT05707637 is actively recruiting participants. Contact the research team at piotr.kulakowskimd@gmail.com for enrollment information.
Where is the NCT05707637 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT05707637 clinical trial?
NCT05707637 is sponsored by Centre of Postgraduate Medical Education. The principal investigator is Piotr Kulakowski, MD PhD at Centre for Medical Postgraduate Education. The trial plans to enroll 100 participants.