Ablation of Clinical Ventricular Tachycardia Versus Addition of Substrate Ablation on the Long Term Success Rate of VT Ablation

Ventricular Tachycardia Clinical Trial

— VISTA  

Official title:

Comparison of the Effect of Ablation of the Clinically Presenting Ventricular Tachycardia (VT) Only Versus the Addition of Substrate Ablation Based on Scar Mapping; on the Long Term Success Rate of VT Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045668
• Other study ID #: TCAI-VISTA
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2010
• Last updated: August 21, 2014
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims to assess whether a combined technique of substrate ablation and ablation of the clinically presenting VT at the site of early activation is superior to ablation of the clinically presenting VT alone, in enhancing long-term success of VT ablation.

Description:

Background: VT is found mostly in patients with structural heart disease. It is classified using morphological criteria (monomorphic or polymorphic), duration of arrhythmia (sustained or non-sustained) or the mechanism of arrhythmia formation (re-entry, increased automation or triggered activity). The therapeutic approach and prognostic estimates of these different types of VT depend to a great degree on the mechanistic basis of the disease as well as the extent of myocardial damage and success of the therapy is measured by the absence of recurrence.

Myocardial infarction with subsequent induction of VT is observed as a consequence of coronary artery disease (CAD). The infarct regions that are morphologically and electrically diseased can be arrhythmogenic and may form the substrate for macro-reentrant VT.

Although antiarrhythmic drugs remain the primary form of therapy for VT, non-pharmacologic techniques like implantable cardioverter-defibrillator (ICD) and catheter ablation (CA) are becoming increasingly popular because of advancement in technology as well as an increase in desire among patients to eliminate the arrhythmia with ablation rather than suppressing it with drugs. ICDs and CA effectively terminate VT on a short-term basis; but multiple morphologies, hemodynamic instability and non-inducibility limit the long-term success rate of CA. The 'substrate mapping' approach defines areas of ventricular scar which can be potential VT sources. Several studies on small groups of patients have shown that successful ablation of VT substrates either reduces the recurrence of VT to 19- 50% or reduces the frequency of recurrence as well as the requirement of anti-arrhythmic drugs (AADs).

Study design:

This study is a multicenter, randomized, open label, parallel-arm clinical trial. A total of 120 post-myocardial infarction patients will be randomized at a 1:1 ratio into 2 groups:

1. ablation targeting the clinically presenting VT at the site of early activation only, or

2. ablation targeting the clinically presenting VT at the site of early activation plus substrate-based RF ablation

Follow-up:

Patients will undergo ICD interrogation at 3, 6 and 12 months to collect VT episode data, VT symptom assessment, complication assessment and AAD records. Management of AADs will be at the discretion of the physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Previous Myocardial infarction

• Symptomatic, drug-refractory and haemodynamically stable VT following CAD

• Undergoing a VT ablation

• Implanted ICD

Exclusion Criteria:

• Documented valvular heart disease

• Acute myocardial infarction within the preceding 1 month

• Unstable angina

• Prolonged QT interval

• Patients with hemorrhagic or thrombophilic disorders

• Documented intra-atrial thrombus, tumor or other conditions which prevent easy catheter introduction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• Radiofrequency Catheter Ablation (RFCA)
RFCA of clinical VT
• Radiofrequency Catheter Ablation (RFCA)
RFCA of clinical VT as well as VT substrates

Locations

Country	Name	City	State
United States	St.David's Medical Center	Austin	Texas

Sponsors (10)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation	California Pacific Medical Center, Case Western Reserve University, Catholic University, Italy, Ospedale dell'Angelo, Mestre, Venice, Italy, RCCS Monzino Hospital, Milan, Italy, Southlake Regional Health Centre, Stanford University, University of Kansas Medical Center, University of Rome Tor Vergata

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of any sustained VT in the post-ablation period as demonstrated by electronic documentation Procedural complications associated with prolonged use of radiofrequency (RF) energy such as perforation, cardiac tamponade		48 hours	Yes
Secondary	Severe clinical events (hospital admissions for a cardiac cause, syncopal attacks, number of episodes of VT storms, death) Number of ICD interventions		12 months	Yes