Ventricular Tachycardia (VT)
Conditions
Keywords
Ventricular Tachycardia, VT, Non-Invasive Programmed Stimulation, NIPS, ICD, Implantable Cardioverter Defibrillator
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERe-Do ventricular tachycardia ablation
1\. Programmed ventricular stimulation (PVS); 2. Mapping during Sinus Rhythm (SR) or right ventricular pacing in pacing dependent patients; 3. Late Potentials identification; 4. VT(s) induction with diastolic pathway mapping when possible; 5. Catheter Ablation in SR or, at the operator's discretion, in VT if tolerated by the patient; 6. If VT is not inducible or the diastolic pathway is not mappable, a substrate ablation approach will be performed. 7. PVS is repeatedly attempting to reinduce VT after completing; 8. Endpoint: non-inducibility of any VT.
DRUGAntiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)
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.
Sponsors
IRCCS Ospedale San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with an implanted ICD (all brands) * Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM. * Induction of monomorphic VT at NIPS 3-7days after a successful index procedure * Age 18 years or more * Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol.
Exclusion criteria
* Inducible VT after index procedure * Contraindication to anticoagulants * Presence of thrombi * Presence of Mitral and Aortic prosthetic valve * Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass * Pregnant or nursing * Ventricular Tachycardia caused by reversible pathology * \< 1 Year life expectancy according to the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VT recurrence free survival rate | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of ICD shocks | Procedural, periprocedural, 6 and 12 months after procedure |
| Proportion of patients with VT storm | Procedural, periprocedural, 6 and 12 months after procedure |
| Rate of subsequent hospitalization for VT recurrence/HF. | Procedural, periprocedural, 6 and 12 months after procedure |
| Cardiac mortality | Procedural, periprocedural, 6 and 12 months after procedure |
Countries
Italy
Contacts
CONTACTAndrea Radinovic, MD
CONTACTAnna Montagna, PhD
Outcome results
None listed