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.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
- Compare the prevalence of ST segment changes between polymorphic VT/VF to
monomorphic VT.
- Among the patients that received ICD shock therapy, determine the number,
percentage and type of all inappropriate shocks and characterize the ST segment
changes prior to these events when data is available.
- Comparison of study endpoint analysis against dobutamine stress echo results
- Number, duration and results of all ER/hospital visits due to shocks
- All-cause hospitalizations
- Adverse Events
- Deaths
Background summary
A recently introduce feature available in some ICDs manufactured by St Jude
medical enables the constant beat to beat monitoring of the intra-cardiac ST
segment using the implanted ICD leads. Similar systems have demonstrated this
approach to be a reliable method of identifying ischemic events(19). However,
the predictive value of the ST monitoring feature in identifying pending
arrhythmic events has yet to be established.
Study objective
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.
Study design
Observational multicenter non randomized trial
Study burden and risks
There is no additional risk for the patient.
The burden consists of the additional hospital visits for the group of patients
not using remote monitoring.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01685047 |
| CCMO | NL42233.018.12 |