Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study.
Paolo Della Bella, Giovanni Peretto, Gabriele Paglino...
https://pubmed.ncbi.nlm.nih.gov/32599177Actively Recruiting
Led by IRCCS Ospedale San Raffaele · Updated on 2026-03-27
51
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to evaluate the role of non-invasive programmed stimulation (NIPS) in predicting the risk of ventricular tachycardia (VT) recurrence after catheter ablation and to identify the best treatment approach. It focuses on whether a new VT ablation guided by NIPS results can better reduce VT recurrence compared to antiarrhythmic drug therapy. The study is a prospective, randomized, multicenter trial involving patients with structural heart disease and implanted defibrillators. Participants will be randomized into two groups: one receiving antiarrhythmic drug therapy (amiodarone, sotalol, or mexiletine) and the other undergoing a repeat VT ablation procedure based on NIPS findings. The ablation involves programmed ventricular stimulation, mapping, VT induction, and catheter ablation targeting VT sources. The drug therapy group will either restart or start antiarrhythmic medications per clinical practice. The study compares these approaches starting 3 to 7 days after an initial successful ablation. During the study, participants will be monitored for VT recurrence over 12 months, with assessments including ICD shocks, VT storms, hospitalizations for VT or heart failure, and cardiac mortality at procedural and follow-up time points. The main outcome measured is the VT recurrence-free survival rate one year after the procedure. Participants will have regular evaluations and follow-ups to track their heart rhythm status and treatment effects throughout the study duration.
CONDITIONS
Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure and subsequent drug therapy as clinically indicated
Participants undergo either a Re-Do ventricular tachycardia ablation procedure or receive antiarrhythmic drug therapy to manage ventricular tachycardia.
1 to 2 visits depending on treatment allocation
Duration - Up to 12 months after the procedure
Participants are monitored for ventricular tachycardia recurrence and other clinical outcomes following the treatment phase.
Visits at procedural, periprocedural, 6 months, and 12 months after procedure
Total: 1 location
1
San Raffaele Hospital, Arrhythmology and Electrophysiology unit
Milan, Italy, Italy, 20132
Actively Recruiting
A
Andrea Radinovic, MD
A
Anna Montagna, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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