An Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Abbott Medical Devices
- Primary Endpoint
- Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.
Time Frame: 12 months
Secondary Outcomes
- Quality of Life via Short Form Survey (SF-36)(12 months)
- Number of ICD shocks.(12 months)