Trial Outcomes & Findings for The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock (NCT NCT00787800)
NCT ID: NCT00787800
Last Updated: 2014-07-24
Results Overview
An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Baseline to 12 months after ICD implantation
Results posted on
2014-07-24
Participant Flow
From 2008 to 2010, patients who were undergoing Implantable Cardioverter-Defibrillators (ICD) device implantation at Mayo Clinic in Rochester, Minnesota and Jacksonville, Florida and at two Israeli medical center sites, Sheba Medical Center in Ramat Gan and Carmel Medical Center in Haifa, were screened for entry into this open-label study.
Participant milestones
| Measure |
Dual Chamber ICD
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
47
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Dual Chamber ICD
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
Baseline characteristics by cohort
| Measure |
Dual Chamber ICD
n=50 Participants
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 Participants
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
NYHA Classification
I- No limitation
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
NYHA Classification
II- Limitation with ordinary activity
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
NYHA Classification
III-Limitation with less than daily activity
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
NYHA Classification
IV-Symptoms at rest
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
NYHA Classification
NA-No heart failure
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
NYHA Classification
Heart Failure present but NYHA class not recorded
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
LV Ejection Fraction
|
30.1 Percentage of LV blood volume
STANDARD_DEVIATION 14.1 • n=5 Participants
|
29.6 Percentage of LV blood volume
STANDARD_DEVIATION 13.3 • n=7 Participants
|
29.9 Percentage of LV blood volume
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Co-morbidities
Pulmonary Disease
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Co-morbidities
Diabetes
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Co-morbidities
Hypertension
|
32 participants
n=5 Participants
|
26 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Co-morbidities
Hyperlipidemia
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Co-morbidities
Stroke
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Co-morbidities
Transient Ischemic Attack
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Co-morbidities
History of Paroxysmal Atrial Fibrillation
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Cardiac Disease
Coronary Artery Disease
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Cardiac Disease
Myocardial Infarction
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Cardiac Disease
Percutaneous Coronary Intervention
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Cardiac Disease
Coronary Artery Bypass Graft
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Cardiac Disease
Hypertrophic Cardiomyopathy
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Cardiac Disease
Dilated Cardiomyopathy
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Concomitant Medications
Beta Blocker
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Concomitant Medications
Calcium Channel Blocker
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Concomitant Medications
Amiodarone
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ventricular Depolarization (QRS) Duration
|
112.1 milliseconds
STANDARD_DEVIATION 26.3 • n=5 Participants
|
103.9 milliseconds
STANDARD_DEVIATION 18.2 • n=7 Participants
|
108.4 milliseconds
STANDARD_DEVIATION 23.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months after ICD implantationPopulation: Intent to Treat population analyzed.
An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).
Outcome measures
| Measure |
Dual Chamber ICD
n=50 Participants
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 Participants
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).
Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.
Outcome measures
| Measure |
Dual Chamber ICD
n=50 Participants
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 Participants
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes
|
37 Episodes
|
0 Episodes
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: Intent to Treat population analyzed.
Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
Outcome measures
| Measure |
Dual Chamber ICD
n=50 Participants
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 Participants
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Number of Appropriate Shocks by ICD
|
31 Shocks
|
1 Shocks
|
SECONDARY outcome
Timeframe: BaselinePopulation: Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.
Outcome measures
| Measure |
Dual Chamber ICD
n=23 Participants
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=22 Participants
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Total Cost of ICD Implantation Procedure
|
16,579 US Dollars
Standard Deviation 1,359
|
14,249 US Dollars
Standard Deviation 1,421
|
SECONDARY outcome
Timeframe: Baseline to 12 months after ICD implantationPopulation: Intent to Treat population analyzed.
Outcome measures
| Measure |
Dual Chamber ICD
n=50 Participants
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 Participants
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Number of Subjects With Newly Detected Atrial Tachyarrhythmias
|
12 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Implantation through 1 yearPopulation: Intent to treat analysis population.
AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.
Outcome measures
| Measure |
Dual Chamber ICD
n=50 Participants
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 Participants
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Atrial Fibrillation (AF) Burden
|
0.02 Percentage of atrial arrhythmias per min
Standard Deviation 0.07
|
0 Percentage of atrial arrhythmias per min
Standard Deviation 0
|
Adverse Events
Dual Chamber ICD
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Single Chamber ICD
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dual Chamber ICD
n=50 participants at risk
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 participants at risk
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/50 • Implantation of ICD to one year.
|
4.0%
2/50 • Number of events 2 • Implantation of ICD to one year.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer spreading
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/50 • Implantation of ICD to one year.
|
4.0%
2/50 • Number of events 2 • Implantation of ICD to one year.
|
|
Surgical and medical procedures
Defibrillator Threshold testing could not be done at implant
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Breathing
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Cardiac disorders
Fluid overload
|
0.00%
0/50 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Cardiac disorders
High Blood Pressure
|
0.00%
0/50 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/50 • Number of events 2 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Surgical and medical procedures
Right ventricular lead replaced
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Cardiac disorders
Syncope
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Vascular disorders
Venous thromboembolism
|
0.00%
0/50 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
Other adverse events
| Measure |
Dual Chamber ICD
n=50 participants at risk
Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
|
Single Chamber ICD
n=50 participants at risk
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
|
|---|---|---|
|
Vascular disorders
Hematoma/Seroma
|
4.0%
2/50 • Number of events 2 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Infections and infestations
Infection/Erosion
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax/Hemothorax
|
0.00%
0/50 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Vascular disorders
Phlebitis/Thrombosis/Embolism
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Vascular disorders
Cerebrovascular Accident/Transient Ischemic Attack
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Injury, poisoning and procedural complications
Device dislodgement from ventricle
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Surgical and medical procedures
Device Oversensing-Atrial
|
8.0%
4/50 • Number of events 5 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
|
Surgical and medical procedures
Device Oversensing-Ventricle
|
6.0%
3/50 • Number of events 3 • Implantation of ICD to one year.
|
2.0%
1/50 • Number of events 1 • Implantation of ICD to one year.
|
|
Surgical and medical procedures
Device Failure to Capture-Atrial
|
4.0%
2/50 • Number of events 2 • Implantation of ICD to one year.
|
0.00%
0/50 • Implantation of ICD to one year.
|
Additional Information
Paul A. Friedman, MD, Professor of Medicine
Mayo Clinic
Phone: 507-284-7661
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place