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

This study has been completed.
Sponsor:
Collaborators:
University of Kansas
California Pacific Medical Center
Stanford University
Case Western Reserve University
Southlake Regional Health Centre
Catholic University, Italy
Ospedale dell'Angelo, Mestre, Venice, Italy
RCCS Monzino Hospital, Milan, Italy
Univ Tor Vergata, Rome, Italy
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01045668
First received: January 8, 2010
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Ventricular Tachycardia
Procedure: Radiofrequency Catheter Ablation (RFCA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: January 2010
Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045668

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, Mestre, Venice, Italy
RCCS Monzino Hospital, Milan, Italy
Univ Tor Vergata, Rome, Italy
Investigators
Principal Investigator: Andrea Natale, MD FACC FHRS TCAI, St.David's Medical Center, Austin, TX
  More Information

No publications provided

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
Study First Received: January 8, 2010
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014