Clinical trial NCT01546207: Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
Official title: Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventricular Tachycardia
Catheter Ablation
Tachycardia, Ventricular
Keywords: ventricular tachycardia
catheter ablation
VT
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2012-03-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.

Detailed description: Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 90 years.
* History of coronary artery disease.
* Presence of, or planned for, an ICD prior to discharge.
* Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.

Exclusion Criteria:

* Ventricular arrhythmia not thought to be due to CAD.
* Unstable angina
* CVA within 30 days.
* Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography
* Pregnancy
* Any condition resulting in an absolute contraindication to anticoagulation
* Inability to follow-up at ICD clinic.
* Inability to give informed consent.
* Non-inducible for sustained monomorphic ventricular tachycardia.
* Prior substrate guided ablation.
* Definite need for epicardial ablation, as determined by the primary operator.

Primary outcomes:
measure: Catheter Ablation
timeFrame: at time of catheter ablation procedure (intraoperative)
Secondary outcomes:
measure: ICD Interrogation
timeFrame: baseline and 6 months follow-up
measure: Procedural Safety
timeFrame: 1 week post-op
measure: Signal-Average ECG
timeFrame: baseline and post-op day one after procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel-Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Santa Catarina
country: Brazil
facility: Hospital Regional Sao Jose
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Prague
country: Czechia
facility: Homolka Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: