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

Not Applicable

• Conditions: Ventricular Tachycardias
• Interventions: Procedure: Radiofrequency ablation of ventricular tachycardia; Procedure: Immediate radiofrequency ablation of ventricular tachycardia

• Registration Number: NCT01547208
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-03
• Study First Posted: 2012-03-07
• Study Start: 2012-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-12
• Last Update Posted: 2020-04-14
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 590

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 exclusion Criteria:

• General contraindication to transcatheter ablation
• Contraindication to antithrombotic therapy
• Patients chronically treated with class I and III antiarrhythmic drugs

Phase B exclusion criteria:

• Patients developing first occurrence of incessant VTs
• Patients receiving a shock for first occurrence of clinically verified ventricular fibrillation
• Patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Radiofrequency ablation of ventricular tachycardia	Patients will wait until an arrhythmic storm to undergo a VT ablation procedure
Group A	Immediate radiofrequency ablation of ventricular tachycardia	Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of patients showing VT recurrences during phase B	Two Years
Number of patients showing electrical storm (ES) recurrences during phase B	Two Years
Number of patients showing cardiac deaths during phase B	Two Years

Trial Locations

Locations (21)

Osp. Fondazione Giovanni Paolo II; 🇮🇹 Campobasso, Italy

Ospedale Civile Maggiore; 🇮🇹 Verona, Italy

Hôpital cardiologique du Haut-Lévêque; 🇫🇷 Bordeaux, France

Lausanne Hospital; 🇨🇭 Lausanne, Switzerland

Policlinico Casilino; 🇮🇹 Rome, Italy

Ospedale di Mirano; 🇮🇹 Mirano, Venice, Italy

AO Policlinico di Bari; 🇮🇹 Bari, Italy

IKEM Hospital; 🇨🇿 Prague, Czechia

Brussels Heart Center; 🇧🇪 Bruxelles, Belgium

Herz und Gefass Klinik; 🇩🇪 Bad Neustadt An Der Saale, Germany

Ospedale di Desio; 🇮🇹 Desio, Milan, Italy

Ospedale S. Donato; 🇮🇹 Arezzo, Italy

Ospedale Brotzu; 🇮🇹 Cagliari, Italy

AO Pugliese Ciaccio; 🇮🇹 Catanzaro, Italy

IRCCS San Raffaele; 🇮🇹 Milan, Italy

Azienda Ospedaliera Valtellina e Valchiavenna; 🇮🇹 Sondrio, Italy

Fondazione G. Monasterio; 🇮🇹 Pisa, Italy

Azienda Ospedaliera Sant'Antonio Abate; 🇮🇹 Gallarate, Varese, Italy

Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria; 🇵🇹 Lisbon, Portugal

Ospedale di Montebelluna; 🇮🇹 Montebelluna, Treviso, Italy

Ospedale Mater Domini; 🇮🇹 Castellanza, Varese, Italy