Benign symptomatic premature ventricular complexes: short- and long-term efficacy of antiarrhythmic drugs and radiofrequency ablation.
Sebastian Stec, Agnieszka Sikorska, Beata Zaborska...
https://pubmed.ncbi.nlm.nih.gov/22528707Actively Recruiting
Age: 18Years +
All Genders
ID05707637
Bipolar Radio-frequency Ablation After Standard Unipolar Approach for Ventricular Arrhythmias Originating From the Base of the Heart. The BiUniVA Prospective Registry
Led by Centre of Postgraduate Medical Education · Updated on 2025-05-13
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ventricular arrhythmias (VA) that originate at the base of the heart, focusing on cases where the standard unipolar radio-frequency (RF) ablation treatment fails. This study aims to find out how many patients need a follow-up procedure using bipolar RF ablation, which may be more effective for difficult-to-reach arrhythmias. They also want to identify electrophysiological signals that predict success or failure of these ablation methods and assess how these treatments affect patients’ quality of life. The study involves patients who have already undergone unipolar ablation for VA but may require further treatment. If unipolar ablation does not succeed, patients may receive bipolar ablation, which uses two electrodes to deliver RF energy between adjacent heart structures for deeper tissue treatment. The procedures use advanced mapping and catheter systems to guide ablation. Patients are monitored during the procedures, and coronary angiography is performed to ensure safety. Both unipolar and bipolar ablations are evaluated for their immediate and one-month effectiveness. Participants will have detailed heart studies and electrophysiological tests to guide treatment. They will be assessed before and after ablation with Holter ECG monitoring and quality of life questionnaires. Researchers are measuring the need for bipolar ablation after failed unipolar treatment, how well specific heart signals predict success, and the impact of ablation on symptoms and life quality over two years. Follow-up includes clinical evaluations and tests to track arrhythmia recurrence and treatment outcomes.
CONDITIONS
Brief Title
Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Baseline Holter ECG within 6 months before initial unipolar ablation without antiarrhythmic drugs (beta-blockers allowed)
- Initial unipolar ablation for ventricular arrhythmia originating from the base of the heart performed with detailed electrophysiological measurements
- Typical indications for ablation such as more than 10,000 premature ventricular contractions in 24-hour Holter, at least 10% PVC in 24-hour Holter, symptomatic PVC, at least 3 episodes of symptomatic non-sustained ventricular tachycardia, or sustained ventricular tachycardia
- Written informed consent
You will not qualify if you...
- History of more than one unipolar ablation for ventricular arrhythmia originating at the base of the heart
- Missing properly recorded electrophysiological parameters during baseline unipolar ablation
- Lack of baseline Holter ECG performed within 6 months prior to initial unipolar ablation
- Absence of typical indications for ablation
- Lack of written informed consent for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Initial unipolar ablation procedure followed by bipolar ablation if needed; medium-term assessment at 1 month after each ablation
Participants undergo initial unipolar ablation to treat ventricular arrhythmias originating from the base of the heart. If unipolar ablation fails, bipolar ablation is performed as a redo procedure using two ablation catheters positioned in adjacent heart structures.
1 initial ablation visit and 1 follow-up visit at 1 month; additional ablation visit if bipolar ablation is required
Follow-up
Duration - Up to 2 years
Participants are followed up to assess medium-term efficacy of ablation procedures and quality of life changes using questionnaires before and 1 month after ablation.
Periodic assessments including 24-hour Holter ECG and quality of life questionnaires before and 1 month after ablation; additional follow-up visits as needed for monitoring
Trial Site Locations
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland, 04-073
Actively Recruiting
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Research Team
P
Piotr Kulakowski, MD PhD
A
Agnieszka Sikorska, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Victor Neira, Pasquale Santangeli, Piotr Futyma...
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Jacob S Koruth, Srinivas Dukkipati, Marc A Miller...
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Peter J Sauer, Megan J Kunkel, Duy T Nguyen...
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Piotr Futyma, Jarosław Sander, Kamil Ciąpała...
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Paolo Della Bella, Giovanni Peretto, Gabriele Paglino...
https://pubmed.ncbi.nlm.nih.gov/32599177Acute and long-term results of bipolar radiofrequency catheter ablation of refractory ventricular arrhythmias of deep intramural origin.
Miyako Igarashi, Akihiko Nogami, Seiji Fukamizu...
https://pubmed.ncbi.nlm.nih.gov/32353585Bipolar ablation of therapy-refractory ventricular arrhythmias: application of a dedicated approach.
Shinwan Kany, Fares Alexander Alken, Ruben Schleberger...
https://pubmed.ncbi.nlm.nih.gov/34922350