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A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias (inSighT)

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ClinicalTrials.gov Identifier: NCT01685047
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this investigation is to determine the prevalence of device-recorded ST segment changes occurring before appropriate ICD therapies (ATP or Shock) and to define their temporal relationship to ventricular arrhythmias.

Condition or disease
Coronary Artery Disease

Study Design

Study Type : Observational
Actual Enrollment : 481 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias
Study Start Date : December 2012
Primary Completion Date : January 2016
Study Completion Date : April 2016
Groups and Cohorts

Group/Cohort
Merlin.net
Group 1 uses Merlin.net for remote monitoring, i.e. scheduled follow ups every 6 months in clinic, collection of ST Segment, ATP and Shock Therapy delivered alerts via Merlin.net.
Non Merlin.net

Group 2 will not use Merlin.net, i.e. scheduled follow ups every 3 months in clinic for alert review during device interrogation.

The use of Merlin.net will be per physician's preference.



Outcome Measures

Primary Outcome Measures :
  1. Among patients with an appropriate ICD therapy (shock or ATP) for ventricular tachycardia or fibrillation, determine the proportion of patients who have characterized ST segment changes from baseline prior to the therapy. [ Time Frame: End of follow up period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient is implanted with SJM ICD and has or is at high risk of CAD
Criteria

Inclusion Criteria:

  • The patient is implanted with an SJM ICD with ST Monitoring and ShockGuard™ features (and remote care feature in case Merlin.net will be used)
  • The patient, in the opinion of the investigator, will not require ventricular pacing for more than 20% of the time.
  • The patient, in the opinion of the investigator, has or is at high risk of CAD.
  • The patient is ≥ 18 years of age.
  • The patient is able to provide written Informed Consent prior to any investigational related procedure.

Exclusion Criteria:

  • The patient has longstanding persistent AF/AFl or permanent AF/AFl
  • The patient has documented complete heart block.
  • The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on regular basis).
  • The patient has severe Left Ventricular Hypertrophy resulting in interventricular conduction defect (IVCD).
  • The patient has intermittent bundle branch blocks (BBB).
  • The patient is unable to comply with the follow up schedule.
  • The patient is participating in another investigational device or drug investigation.
  • The patient is pregnant or is planning to become pregnant during the duration of the investigation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685047


Locations
Germany
Kerckhoff Klinik
Bad Nauheim, Germany, D-61231
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Johannes SPERZEL, MD Kerckhoff Klinik, Bad Nauheim Germany
More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01685047     History of Changes
Other Study ID Numbers: CR-12-014-ID-HV
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016

Keywords provided by St. Jude Medical:
Coronary Artery Disease
Ventricular Arrhythmias
ST Segment Changes

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases