Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.

Last updated: February 1, 2019
Sponsor: Abbott Medical Devices
Overall Status: Trial Not Available

Phase

N/A

Condition

Heart Defect

Fast Heart Rate (Tachycardia)

Heart Disease

Treatment

N/A

Clinical Study ID

NCT02584595
SJM-CIP-10068
  • Ages 18-75
  • All Genders

Study Summary

The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillation (CRT-D) systems.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patient is receiving a new SJM ICD or CRT-D implant system, which has study requiredprograming capabilities and is appropriate for remote monitoring. Patients who havereceived the ICD or CRT-D up to 30 days prior to enrollment are also eligible. Patient consents to have a NIPS/EP study. Patient has documented Ejection Fraction (EF) < 50% and / or Right Ventricular (RV)dysfunction. Patient has documented structural cardiomyopathy of any kind >1 month. Patient is between 18 to 75 years of age. Patient has been informed of the nature of the study and has agreed to its provisions andprovided written informed consent using a form approved by the Institutional ReviewBoard/Ethics Committee (IRB/EC).

Exclusion

Exclusion Criteria: Patient has history of stroke. Patient has had ST Segment elevation myocardial infarction (MI); or previous cardiacsurgery within 60 days prior to enrollment. Patient is pregnant or nursing. Patient has chronic New York Heart Association (NYHA) Class IV heart failure. Patient has limited life expectancy according to the investigator (less than one year). Patient has had a recent coronary artery bypass graft (CABG) (< 60 days) or percutaneouscoronary intervention (PCI) (< 30 days). Patient is currently participating in an investigational drug or device study Patient isunable or unwilling to cooperate with the study procedures. Patient has a prosthetic mitral or aortic valve. Patient has mitral or aortic valvular heart disease requiring immediate surgicalintervention. Patient has Left Ventricular EF < 15%. Patient has had a previous ablation procedure for ventricular tachycardia (VT), excludingremote (> 3 months) outflow tract tachycardia. Patient has previously documented history of severe loss of kidney function or kidneyfailure. Patient has premature ventricular contractions (PVC) or VT induced cardiomyopathy expectedto resolve with ablation and will not require an ICD. Patient has reversible cause of VT.

Study Design

Study Start date:
September 01, 2015
Estimated Completion Date:
February 28, 2022

Study Description

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

This study provides a mechanism for sites to refer subjects for potential enrollment to the Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) Investigational Device Exemption (IDE) study (ClinicalTrials.gov NCT02130765).

Patients receiving ICD or CRT-D device implant (or have received it within 30 days) may be enrolled in the study.