N/A
N=481
A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01685047 ↗Enrolled (actual)
481
Serious AEs
30.6%
Results posted
Jan 2019
Primary outcome: Primary: Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated. — 56 participants — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated. |
56 | <0.05 sig |
Summary
The purpose of this investigation is to determine the prevalence of device-recorded ST segment changes occurring before appropriate Implantable Cardiac Defibrillator (ICD) therapies (ATP or Shock) and to define their temporal relationship to ventricular arrhythmias.
Eligibility Criteria
Inclusion Criteria
- The patient is implanted with an St Jude Medical (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 Coronary Artery Disease (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 Atrial Fibrillation (AF) /Atrial Flutter (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.
Data sourced from ClinicalTrials.gov (NCT01685047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.