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Completed

NCT Number: NCT01045668

Ablation of Clinical Ventricular Tachycardia Versus Addition of Substrate Ablation 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St.David's Medical Center

Austin, Texas, 78705, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency Catheter Ablation (RFCA)

Procedure

RFCA of clinical VT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Texas Cardiac Arrhythmia Research Foundation

Other

Collaborators

  • California Pacific Medical Center
  • Case Western Reserve University
  • Catholic University, Italy
  • Ospedale dell'Angelo, Venezia-Mestre
  • RCCS Monzino Hospital, Milan, Italy
  • Southlake Health
  • Stanford University
  • University of Kansas
  • University of Rome Tor Vergata

Registry information

Official study 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

Acronym: VISTA

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jan 11, 2010
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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