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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Procedure: Radiofrequency Catheter Ablation (RFCA); Procedure: Radiofrequency Catheter Ablation (RFCA)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • St.David's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Clinical VT ablation	Procedure: Radiofrequency Catheter Ablation (RFCA); RFCA of clinical VT; Procedure: Radiofrequency Catheter Ablation (RFCA); RFCA of clinical VT as well as VT substrates
ACTIVE_COMPARATOR: clinical VT and substrate ablation	Procedure: Radiofrequency Catheter Ablation (RFCA); RFCA of clinical VT; Procedure: Radiofrequency Catheter Ablation (RFCA); RFCA of clinical VT as well as VT substrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Severe clinical events (hospital admissions for a cardiac cause, syncopal attacks, number of episodes of VT storms, death) Number of ICD interventions	12 months

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Collaborators: Stanford University; University of Rome Tor Vergata; Case Western Reserve University; University of Kansas; California Pacific Medical Center; Southlake Regional Health Centre; Catholic University, Italy; RCCS Monzino Hospital, Milan, Italy; Ospedale dell'Angelo, Venezia-Mestre
• Investigators: Principal Investigator: Andrea Natale, MD FACC FHRS, TCAI, St.David's Medical Center, Austin, TX

Publications and helpful links

General Publications

• Di Biase L, Burkhardt JD, Lakkireddy D, Carbucicchio C, Mohanty S, Mohanty P, Trivedi C, Santangeli P, Bai R, Forleo G, Horton R, Bailey S, Sanchez J, Al-Ahmad A, Hranitzky P, Gallinghouse GJ, Pelargonio G, Hongo RH, Beheiry S, Hao SC, Reddy M, Rossillo A, Themistoclakis S, Dello Russo A, Casella M, Tondo C, Natale A. Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy: The VISTA Randomized Multicenter Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2872-2882. doi: 10.1016/j.jacc.2015.10.026.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (ESTIMATE): January 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 25, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: TCAI-VISTA