A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias (inSighT)
Verified January 2014 by St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
First received: September 11, 2012
Last updated: January 30, 2014
Last verified: January 2014
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.
||Observational Model: Case Control
Time Perspective: Prospective
||A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patient is implanted with SJM ICD and has or is at high risk of CAD
- 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.
- 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.
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
St. Jude Medical
||Johannes SPERZEL, MD
||Kerckhoff Klinik, Bad Nauheim Germany
No publications provided
||St. Jude Medical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 11, 2012
||January 30, 2014
||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
ST Segment Changes
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Coronary Artery Disease
Arterial Occlusive Diseases