San Raffaele Hospital, Arrhythmology and Electrophysiology unit
Milan, Italy, 20132
Location status: Recruiting
Location contact
Andrea Radinovic, MD
CONTACT
Paolo Della Bella, MD
CONTACT
NCT Number: NCT06669299
The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Milan, Italy, 20132
Location status: Recruiting
Andrea Radinovic, MD
CONTACT
Paolo Della Bella, MD
CONTACT
The value of non-invasive programmed ventricular stimulation (NIPS) in the setting of ablation of ventricular tachycardia (VT) in patients with structural heart disease has been the object of studies in the last decade.
The technique is based on the feature, uniformly available in the Implantable Cardioverter-Defibrillator (ICD), to perform a complete programmed stimulation study from the apex of the right ventricle to assess the inducibility of ventricular tachycardia, similar to what is routinely performed during an invasive electrophysiology procedure. Data from our group indicate that 26% of patients who were non-inducible (apparent success) at the end of the ablation session become re-inducible to ventricular tachycardia at "late" NIPS (day 6). This finding, possibly related to partial recovery of conduction within the treated area, had prognostic significance, as it was associated with a 6-fold increased risk of VT recurrence at follow-up.
Recently Muser et al. reported similar findings (45/216 -21% of patients had clinical VT induced) with "late" NIPS performed on day 3. However, within this group of patients, the VT recurrence rate was significantly lower in those who had undergone, based on this finding, a re-do VT ablation as compared to those treated conservatively (rec in 1/11 of the Re-do ablation group, 9% vs. 24/34 in the conservative treatment group, 71%, p<0.01).
These data, however, originated from a retrospective observational analysis, where the indication of ablation was based on empirical physician preference.
No prospective randomized data compare the conservative attitude versus performing a new ablation in subjects who did not obtain a stable result after the first one. Therefore, this randomized multicenter clinical study aims to evaluate whether the repetition (Re-Do) of VT ablation process is superior to conservative medical therapy for reducing VT recurrences on post-procedural NIPS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients with a positive NIPS already on antiarrhythmic drugs (AAD) before the index procedure will re-start the original antiarrhythmic therapy. Patients who were not on AAD will start a new drug at the operator's discretion (amiodarone, sotalol, or mexiletine) according to clinical practice.
Time frame: 12 months after the procedure
Compare the efficacy on the reduction of VT recurrence of a NIPS-based Re-Do VT ablation versus antiarrhythmic drug therapy
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Contact information is provided by the study sponsor or research team.
Andrea Radinovic, MD
CONTACT
Anna Montagna, PhD
CONTACT
IRCCS Ospedale San Raffaele
Other
The Value of Late Non-Invasive Programmed Stimulation (NIPS) in the Setting of Ventricular Tachycardia (VT) Ablation to Guide the Subsequent VT Therapeutic Strategies: a Prospective Randomized Multicenter Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06703489
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Boston, Massachusetts, United States
View Trial DetailsNCT07024927
Arrhythmias, Cardiac, Atrial Fibrillation
Beijing, Beijing Municipality, China
View Trial DetailsNCT06745778
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Wenzhou, Zhejiang, China
View Trial DetailsNCT06744530
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Leuven, Belgium
View Trial Details