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

NCT ID: NCT02130765

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-07-25

Brief 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.

Detailed 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.

Conditions

Monomorphic Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug with ICD/CRT-D

Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cardiac catheter ablation with ICD/CRT-D

Cardiac catheter ablation with ICD/CRT-D with routine drug therapy

Group Type: ACTIVE_COMPARATOR

Cardiac catheter ablation with ICD/CRT-D

Intervention Type: DEVICE

Cardiac ablation catheter system

Interventions

Cardiac catheter ablation with ICD/CRT-D

Cardiac ablation catheter system

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Francis Marchlinski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

USC University Hospital

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, 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

Washington Hospital Center

Washington D.C., District of Columbia, United States

Emory University Hospital

Atlanta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

Mid-America Cardiology Associates

Kansas City, Kansas, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins University Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Washington University School of Medicine - Barnes Jewish Hospital

St Louis, Missouri, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

New York University Hospital

New York, New York, United States

New York University Langone Medical Center

New York, New York, United States

Mt. Sinai Hospital

New York, New York, United States

Staten Island University Hospital - North

Staten Island, New York, United States

Sanger Clinic

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Memorial Hermann Hospital

The Woodlands, Texas, United States

Intermountain Heart Rhythm Specialist

Murray, Utah, United States

University of Washington Medical Center

Seattle, Washington, United States

Royale Adelaide Hospital

Adelaide, , Australia

Hopital d'adulte de la Timone

Marseille, Alpes, France

CHU Trousseau

Chambray-lès-Tours, Centre-Val de Loire, France

Clinique Protestante

Lyon, , France

Hôpital du Haut Lévêque

Pessac, , France

Ospedale San Raffaele

Milan, Lombardy, Italy

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Kings College Hospital

London, , United Kingdom

Countries

United States; Australia; France; Italy; United Kingdom

Other Identifiers

SJM-CIP-0005

Identifier Type: -

Identifier Source: org_study_id