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

San Donato Group (GSD)

Status: Unknown

Conditions: Ventricular Tachycardias

Treatments: Procedure: Immediate radiofrequency ablation of ventricular tachycardia; Procedure: Radiofrequency ablation of ventricular tachycardia

Study type: Interventional

Funder types: Other

Identifiers

NCT01547208

PARTITA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 590 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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590 participants in 2 patient groups

Group A

Experimental group

Description:

Patients will be randomized to a VT ablation procedure immediately after an appropriate ICD shock

Treatment:

Procedure: Immediate radiofrequency ablation of ventricular tachycardia

Group B

Active Comparator group

Description:

Patients will wait until an arrhythmic storm to undergo a VT ablation procedure

Treatment:

Procedure: Radiofrequency ablation of ventricular tachycardia