Trial Outcomes & Findings for A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias (NCT NCT01685047)
NCT ID: NCT01685047
Last Updated: 2019-08-28
Results Overview
Recruitment status
COMPLETED
Target enrollment
481 participants
Primary outcome timeframe
Until the end of follow up period
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Patient Population
Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
|
|---|---|
|
Overall Study
STARTED
|
481
|
|
Overall Study
COMPLETED
|
396
|
|
Overall Study
NOT COMPLETED
|
85
|
Reasons for withdrawal
| Measure |
Patient Population
Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
20
|
|
Overall Study
Death
|
26
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Physician Decision
|
25
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
patient withdrawn by sponsor
|
1
|
Baseline Characteristics
A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias
Baseline characteristics by cohort
| Measure |
Patient Population
n=480 Participants
Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
|
|---|---|
|
Age, Continuous
|
63.95 years
STANDARD_DEVIATION 11.29 • n=99 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
400 Participants
n=99 Participants
|
|
Indication for Implant
Primary prevention
|
296 participants
n=99 Participants
|
|
Indication for Implant
Secondary prevention
|
184 participants
n=99 Participants
|
|
Medical History
Arrhythmogenic RV cardiomyopathy
|
3 participants
n=99 Participants
|
|
Medical History
Diabetic cardiomyopathy
|
3 participants
n=99 Participants
|
|
Medical History
Dilated cardiomyopathy
|
93 participants
n=99 Participants
|
|
Medical History
Hypertrophic cardiomyopathy
|
9 participants
n=99 Participants
|
|
Medical History
Inschemic cardiomyopathy
|
366 participants
n=99 Participants
|
|
Medical History
Non Ischemic cardiomyopathy
|
12 participants
n=99 Participants
|
|
Medical History
Obesity associated cardiomyopathy
|
1 participants
n=99 Participants
|
|
Medical History
Other
|
23 participants
n=99 Participants
|
|
Atrial Arrhythmia history
Atrial Fibrillation
|
76 participants
n=99 Participants
|
|
Atrial Arrhythmia history
Atrial Flutter
|
14 participants
n=99 Participants
|
|
Ventricular Arrhythmia history
Premature ventricular contractions
|
27 participants
n=99 Participants
|
|
Ventricular Arrhythmia history
Monomorphic ventricular tachycardia
|
107 participants
n=99 Participants
|
|
Ventricular Arrhythmia history
Ventricular fibrillation
|
79 participants
n=99 Participants
|
|
Ventricular Arrhythmia history
Polymorphic ventricular tachycardia
|
10 participants
n=99 Participants
|
|
Ventricular Arrhythmia history
Other
|
23 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Until the end of follow up periodPopulation: The other subjects enrolled in this study had no treated VT/VF events.
Outcome measures
| Measure |
Patient Population
n=245 VT/VF events
Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
|
|---|---|
|
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
|
Adverse Events
Patient Population
Serious events: 147 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient Population
n=481 participants at risk
Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
|
|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Arrhythmia
|
6.0%
29/481 • Number of events 37 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Cardiac arrest
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Component failure
|
0.83%
4/481 • Number of events 4 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Death - Cardiovascular related
|
0.62%
3/481 • Number of events 3 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
General disorders
Death - Non cardiovascular related
|
0.62%
3/481 • Number of events 3 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
General disorders
Death - Unknown
|
1.0%
5/481 • Number of events 5 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Drug Reaction
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Exacerbation of Heart failure
|
4.8%
23/481 • Number of events 33 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Gastrointestinal disorders
Gastro-enteritis
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Inappropriate high voltage therapy
|
1.5%
7/481 • Number of events 7 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Infections and infestations
Infection related to system and/or procedure
|
0.62%
3/481 • Number of events 3 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Ischemic Cardiomyopathy
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Lead dislodgement or migration
|
1.0%
5/481 • Number of events 5 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Surgical and medical procedures
Inappropriate device function
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
6/481 • Number of events 7 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Vascular disorders
Other cardiovascular related event
|
6.2%
30/481 • Number of events 35 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Surgical and medical procedures
Other non cardiovascular
|
12.7%
61/481 • Number of events 71 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
2/481 • Number of events 3 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Blood and lymphatic system disorders
Thromboemboli
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Blood and lymphatic system disorders
Transient Ischemic Attack
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Blood and lymphatic system disorders
Veinthrombosis
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
Other adverse events
| Measure |
Patient Population
n=481 participants at risk
Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
2.5%
12/481 • Number of events 15 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Exacerbation of heart failure
|
0.42%
2/481 • Number of events 2 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Inappropriate High Voltage therapy
|
1.5%
7/481 • Number of events 7 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Inappropriate low voltage therapy
|
0.83%
4/481 • Number of events 4 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Lead dislodgement or migration
|
0.62%
3/481 • Number of events 3 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Cardiac disorders
Other cardiovascular
|
2.3%
11/481 • Number of events 13 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
General disorders
Other non cardiovascular
|
2.9%
14/481 • Number of events 15 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
device oversensing
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.62%
3/481 • Number of events 3 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Injury, poisoning and procedural complications
Device threshold elevation
|
0.42%
2/481 • Number of events 2 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
|
Blood and lymphatic system disorders
Vein thrombosis
|
0.21%
1/481 • Number of events 1 • Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60