Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medi… (NCT02584595) | Clinical Trial Compass
WithdrawnNot Applicable
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.
Stopped: Business decision
0Started 2015-09
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dis…
What they're measuring
1
Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.