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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01685047
First received: September 11, 2012
Last updated: January 30, 2014
Last verified: January 2014

September 11, 2012
January 30, 2014
December 2012
August 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01685047 on ClinicalTrials.gov Archive Site
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A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias
A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patient is implanted with SJM ICD and has or is at high risk of CAD

Coronary Artery Disease
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  • 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.

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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
470
September 2015
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Karolien Timmermans +3227746741 ktimmermans@sjm.com
Contact: Guillaume Raux, PhD +32 277 468 37 graux@sjm.com
Germany
 
NCT01685047
CR-12-014-ID-HV
No
St. Jude Medical
St. Jude Medical
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Principal Investigator: Johannes SPERZEL, MD Kerckhoff Klinik, Bad Nauheim Germany
St. Jude Medical
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP