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
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 470
Study Start Date: December 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685047

Contacts
Contact: Karolien Timmermans +3227746741 ktimmermans@sjm.com
Contact: Guillaume Raux, PhD +32 277 468 37 graux@sjm.com

Locations
Germany
Kerckhoff Klinik Recruiting
Bad Nauheim, Germany, D-61231
Contact: Johannes Sperzel, MD    +49 6032 996 2239    j.sperzel@kerckhoff-klinik.de   
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Johannes SPERZEL, MD Kerckhoff Klinik, Bad Nauheim Germany
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01685047     History of Changes
Other Study ID Numbers: CR-12-014-ID-HV
Study First Received: September 11, 2012
Last Updated: January 30, 2014
Health Authority: Belgium: Ethics Committee
Canada: Ethics Review Committee
China: Ethics Committee
Finland: Ethics Committee
France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
Hong Kong: Ethics Committee
India: Ethics Committee
Italy: Ethics Committee
Japan: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)
United Kingdom: Department of Health
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014