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

• ClinicalTrials.gov Identifier: NCT01045668
• Recruitment Status: Completed
• First Posted: January 11, 2010
• Last Update Posted: August 25, 2014
• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Collaborators: University of Kansas; California Pacific Medical Center; Stanford University; Case Western Reserve University; Southlake Regional Health Centre; Catholic University, Italy; Ospedale dell'Angelo; RCCS Monzino Hospital, Milan, Italy; University of Rome Tor Vergata
• Information provided by (Responsible Party): Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia	Procedure: Radiofrequency Catheter Ablation (RFCA)	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: January 2010
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Clinical VT ablation	Procedure: Radiofrequency Catheter Ablation (RFCA); RFCA of clinical VT
Active Comparator: clinical VT and substrate ablation	Procedure: Radiofrequency Catheter Ablation (RFCA); RFCA of clinical VT as well as VT substrates

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. Severe clinical events (hospital admissions for a cardiac cause, syncopal attacks, number of episodes of VT storms, death) Number of ICD interventions [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

St.David's Medical Center

Austin, Texas, United States, 78705

Sponsors and Collaborators

Texas Cardiac Arrhythmia Research Foundation

University of Kansas

California Pacific Medical Center

Stanford University

Case Western Reserve University

Southlake Regional Health Centre

Catholic University, Italy

Ospedale dell'Angelo

RCCS Monzino Hospital, Milan, Italy

University of Rome Tor Vergata

Investigators

• Principal Investigator: Andrea Natale, MD FACC FHRS; TCAI, St.David's Medical Center, Austin, TX

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
• ClinicalTrials.gov Identifier: NCT01045668 History of Changes
• Other Study ID Numbers: TCAI-VISTA
• First Posted: January 11, 2010
• Last Update Posted: August 25, 2014
• Last Verified: August 2014

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes