A Clinical Evaluation of ST Changes in a group of Patients having ventricular arrhythmias

Completed

Conditions: ECG shifts
Ventricular arrhythmias
10007521

Registration Number: NL-OMON39693

Lead Sponsor: St. Jude Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Among patients with an appropriate ICD therapy (shock or ATP) for ventricular<br /><br>tachycardia or fibrillation, determine the proportion of patients who have<br /><br>characterized ST segment changes from baseline prior to the therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Compare the prevalence of ST segment changes between polymorphic VT/VF to<br /><br>monomorphic VT.<br /><br>- Among the patients that received ICD shock therapy, determine the number,<br /><br>percentage and type of all inappropriate shocks and characterize the ST segment<br /><br>changes prior to these events when data is available.<br /><br>- Comparison of study endpoint analysis against dobutamine stress echo results<br /><br>- Number, duration and results of all ER/hospital visits due to shocks<br /><br>- All-cause hospitalizations<br /><br>- Adverse Events<br /><br>- Deaths</p><br>