Ventricular Tachycardias
Conditions
Keywords
ICD shocks, Ventricular tachycardias ablation, Timing of ablation, Electrical storm, Arrhythmic storm
Brief summary
The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.
Detailed description
Enrolled patients will remain in a first phase of the study until the first appropriate ICD shock will be delivered. The objective of this first stage is to assess whether the burden of untreated non sustained VTs or episodes treated with anti-tachycardia pacing is predictive of appropriate ICD shocks. The second phase of the study will start after the first appropriate ICD shock delivered for VT. Patients will be then randomized to immediate VT ablation or to standard treatment, meaning waiting until next arrhythmic storm to perform a VT ablation procedure. The objective of this phase is compare the rate of worsening heart failure hospitalizations and deaths from any cause between the two groups.
Interventions
PROCEDUREImmediate radiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
PROCEDURERadiofrequency ablation of ventricular tachycardia
Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death
Exclusion criteria
Phase A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of the first appropriate ICD shock during phase A | Event Driven |
| Number of patients showing worsening heart failure hospitalizations or deaths from any cause during phase B | Two Years |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients showing cardiac deaths during phase B | Two Years |
| Number of patients showing electrical storm (ES) recurrences during phase B | Two Years |
| Number of patients showing VT recurrences during phase B | Two Years |
Countries
Belgium, Czechia, France, Germany, Italy, Portugal, Switzerland
Contacts
Primary ContactAndrea Radinovic
Backup ContactPaolo Della Bella
Outcome results
None listed