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.

NCT02584595 | Withdrawn

• 1 other identifier: SJM-CIP-10068
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Monomorphic Ventricular Tachycardia

Keywords

Tachycardia; Ventricular Tachycardia; Cardiac Arrhythmias; Cardiovascular Diseases; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.

  12 months

Secondary Outcomes (2)

• Number of ICD shocks.

  12 months

• Quality of Life via Short Form Survey (SF-36)

  12 months

Interventions

ICD/CRT-D with NIPS or EP Study DEVICE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The primary study population includes patients who meet all inclusion/exclusion criteria, has had or will have market-approved St. Jude Medical ICD or CRT-D device systems implanted, and has no history of MMVT.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

MeSH Terms

Conditions

Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 22, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 4, 2019

Record last verified: 2019-02