NCT01045668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

3.5 years

First QC Date

January 8, 2010

Last Update Submit

August 21, 2014

Conditions

Ventricular Tachycardia

Outcome Measures

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

    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

    12 months

Study Arms (2)

Clinical VT ablation

ACTIVE COMPARATOR
Procedure: Radiofrequency Catheter Ablation (RFCA)

clinical VT and substrate ablation

ACTIVE COMPARATOR
Procedure: Radiofrequency Catheter Ablation (RFCA)

Interventions

Radiofrequency Catheter Ablation (RFCA)PROCEDURE

RFCA of clinical VT

Clinical VT ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous Myocardial infarction
  • Symptomatic, drug-refractory and haemodynamically stable VT following CAD
  • Undergoing a VT ablation
  • Implanted ICD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.David's Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (1)

  • 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.

    PMID: 26718674DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Andrea Natale, MD FACC FHRS

    TCAI, St.David's Medical Center, Austin, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Medical Director

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2014

Last Updated

August 25, 2014

Record last verified: 2014-08

Locations

US(1)