NCT01547208

Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 590 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardias

Interventions

Type	Name	Description
PROCEDURE	Immediate radiofrequency ablation of ventricular tachycardia	Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
PROCEDURE	Radiofrequency ablation of ventricular tachycardia	Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs

Timeline

• Start date: 2012-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2012-03-07
• Last updated: 2020-04-14

Locations

21 sites across 7 countries: Belgium, Czechia, France, Germany, Italy, Portugal, Switzerland