Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia

Monomorphic Ventricular Tachycardia Clinical Trial

— STAR-VT  

Official title:

Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02130765
• Other study ID #: SJM-CIP-0005
• Status: Terminated
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 25, 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

Description:

Approximately 50 centers in the United States (US) will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: July 25, 2016
• Est. primary completion date: July 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible.

• Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)** by one or more of the following:

Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study

• 18 to 75 years of age

• Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board.

• Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not.

Exclusion Criteria:

• Any history of stroke

• S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment

• Patient is pregnant or nursing

• Patient has New York Heart Association (NYHA) class IV heart failure

• Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (=3) hours)

• Patient has VT/VF thought to be from channelopathies

• Limited life expectancy (less than one year) according to Investigator

• Patient has current class IV angina

• Recent coronary artery bypass graft (CABG < 60 days) or percutaneous coronary intervention (PCI < 30 days)

• Patient is currently participating in another investigational drug or device study

• Patient is unable or unwilling to cooperate with the study procedures

• Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram (TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS > 1

• Prosthetic mitral or aortic valve

• Mitral or aortic valvular heart disease requiring immediate surgical intervention

• Major contraindication to anticoagulation therapy or coagulation disorder

• Left Ventricular Ejection Fraction < 15%

• Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (> 3 months) outflow tract tachycardia

• Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2 within the past 3 months

• Patient has peripheral vascular disease that precludes LV access

• Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD

• Patient has reversible cause of VT

• Use of left ventricular assist device (LVAD) or Tandem Heart devices (Impella and Balloon pumps are acceptable)

• There is a strong clinical reason to believe that, in the opinion of the investigator, the patient only has septal scar that is deep

Related Conditions & MeSH terms

• Monomorphic Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• Cardiac catheter ablation with ICD/CRT-D
Cardiac ablation catheter system

Locations

Country	Name	City	State
Australia	Royale Adelaide Hospital	Adelaide
France	CHU Trousseau	Chambray-lès-Tours	Centre
France	Clinique Protestante	Lyon
France	Hopital d'adulte de la Timone	Marseille	Alpes
France	Hôpital du Haut Lévêque	Pessac
Italy	Ospedale San Raffaele	Milano	Lombardy
United Kingdom	Kings College Hospital	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne	Tyne And Wear
United States	Emory University Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Sanger Clinic	Charlotte	North Carolina
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	The Methodist Hospital	Houston	Texas
United States	Mid-America Cardiology Associates	Kansas City	Kansas
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Intermountain Heart Rhythm Specialist	Murray	Utah
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee
United States	Mt. Sinai Hospital	New York	New York
United States	New York University Hospital	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	Washington University School of Medicine - Barnes Jewish Hospital	Saint Louis	Missouri
United States	University of California at San Diego (UCSD) Medical Center	San Diego	California
United States	University of California at San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Staten Island University Hospital - North	Staten Island	New York
United States	Memorial Hermann Hospital	The Woodlands	Texas
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  France,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Experienced an ICD Shock Event.	Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up	12 months
Primary	Number of Subjects Who Experienced a Select Serious Adverse Event	Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.	30 days
Secondary	Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit	Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.	12 months