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.

NCT ID: NCT02584595

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2022-02-28

Brief 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.

Detailed 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.

Conditions

Monomorphic Ventricular Tachycardia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ICD/CRT-D with NIPS or EP Study

ICD/CRT-D implanted patients are tested for inducible MMVT during electrophysiology (EP) Study or Non-Invasive Programmed Stimulation (NIPS) Study

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patient is receiving a new SJM ICD or CRT-D implant system, which has study required programing capabilities and is appropriate for remote monitoring. Patients who have received 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 and provided written informed consent using a form approved by the Institutional Review Board/Ethics Committee (IRB/EC).

Exclusion Criteria

Patient has history of stroke.

Patient has had ST Segment elevation myocardial infarction (MI); or previous cardiac surgery 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 percutaneous coronary intervention (PCI) (< 30 days).

Patient is currently participating in an investigational drug or device study Patient is unable 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 surgical intervention.

Patient has Left Ventricular EF < 15%.

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

Patient has previously documented history of severe loss of kidney function or kidney failure.

Patient has premature ventricular contractions (PVC) or VT induced cardiomyopathy expected to resolve with ablation and will not require an ICD.

Patient has reversible cause of VT.

• 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

Other Identifiers

SJM-CIP-10068

Identifier Type: -

Identifier Source: org_study_id