Health TrialsbyHealthPanel

Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies

ConditionVentricular Tachycardia (VT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Ospedale San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inducible VT after index procedure

Contraindication to anticoagulants

Presence of thrombi

Presence of Mitral and Aortic prosthetic valve

Trial design

Design model

Parallel

Treatments tested in this trial

  • Re-Do ventricular tachycardia ablation

    Procedure/Surgery

    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.

  • Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)

    Drug

    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.

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

VT recurrence free survival rate

Compare the efficacy on the reduction of VT recurrence of a NIPS-based Re-Do VT ablation versus antiarrhythmic drug therapy

Time frame
12 months after the procedure

Secondary outcomes

1

Number of ICD shocks

Time frame
Procedural, periprocedural, 6 and 12 months after procedure
2

Proportion of patients with VT storm

Time frame
Procedural, periprocedural, 6 and 12 months after procedure
3

Rate of subsequent hospitalization for VT recurrence/HF.

Time frame
Procedural, periprocedural, 6 and 12 months after procedure
4

Cardiac mortality

Time frame
Procedural, periprocedural, 6 and 12 months after procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Ospedale San Raffaele

Lead sponsor

Source ClinicalTrials.gov
Apply now