Trial Outcomes & Findings for The EASYTRAK EPI Clinical Investigation (NCT NCT00158925)
NCT ID: NCT00158925
Last Updated: 2017-05-31
Results Overview
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
3 months
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
EASYTRAK EPI Implant Group
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The EASYTRAK EPI Clinical Investigation
Baseline characteristics by cohort
| Measure |
EASYTRAK EPI Lead
n=96 Participants
Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.
EASYTRAK EPI lead: EASYTRAK EPI lead
|
|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu periodm the mean pacing threshold was obtained.
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Outcome measures
| Measure |
EASYTRAK EPI Implant Group
n=80 Participants
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
Chronic Pacing Thresholds at 3 Months
|
0.9 V
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu period, the mean impedance was measured.
The expected mean impedance is 500 Ohms.
Outcome measures
| Measure |
EASYTRAK EPI Implant Group
n=80 Participants
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
Chronic Pacing Impedances at 3 Months
|
500 Ohms
Standard Deviation 137
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Although 96 subjects were implanted/attempted, for 67 subjects still in follow up at the end of the 3M fu period, chronic sensing amplitude was measured.
The expected mean is 10mV.
Outcome measures
| Measure |
EASYTRAK EPI Implant Group
n=67 Participants
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
Chronic Sensing Amplitudes at 3 Months
|
15.8 mV
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: 3 monthsThe estimated target value for this endpoint is 80%.
Outcome measures
| Measure |
EASYTRAK EPI Implant Group
n=96 Participants
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
Lead-related Complication-free Rate at 3 Months
|
97.9 % of complication free-rate
Interval 95.5 to 100.0
|
SECONDARY outcome
Timeframe: ImplantPopulation: Although 96 subjects were implanted/attempted, lead implant time was only collected for 69 subjects.
The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.
Outcome measures
| Measure |
EASYTRAK EPI Implant Group
n=69 Participants
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
Lead Implant Time
|
1.47 h.min
Standard Deviation 1.05
|
Adverse Events
EASYTRAK EPI Implant Group
Serious events: 55 serious events
Other events: 49 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
EASYTRAK EPI Implant Group
n=96 participants at risk
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
Cardiac disorders
Unable to capture-LV
|
2.1%
2/96 • Number of events 2
|
|
Cardiac disorders
Impedance>2000 Ohms LV lead
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Dislodgment-no reported signs-LV
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Dislodgment-multiple signs-LV
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Dislodgment-Unable to capture-LV
|
3.1%
3/96 • Number of events 3
|
|
Cardiac disorders
Extracardiac stimulation-RV
|
1.0%
1/96 • Number of events 1
|
|
Infections and infestations
Infection (>30 days post implant)
|
2.1%
2/96 • Number of events 2
|
|
Infections and infestations
Systemic infection
|
1.0%
1/96 • Number of events 1
|
|
Renal and urinary disorders
Post-up urinary retention
|
2.1%
2/96 • Number of events 2
|
|
Endocrine disorders
Elevated blood glucose
|
1.0%
1/96 • Number of events 1
|
|
Vascular disorders
Hemorrhage-procedural related
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Migration
|
1.0%
1/96 • Number of events 1
|
|
Vascular disorders
Thromboembolic events
|
3.1%
3/96 • Number of events 4
|
|
Surgical and medical procedures
Dehiscence of incision over PG
|
1.0%
1/96 • Number of events 1
|
|
Vascular disorders
Vasovagal symptoms
|
1.0%
1/96 • Number of events 1
|
|
Infections and infestations
Post-surgical infection (<30 days post-implant)
|
3.1%
3/96 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax-procedure
|
1.0%
1/96 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hematoma-pocket
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
7.3%
7/96 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.3%
7/96 • Number of events 8
|
|
Blood and lymphatic system disorders
Hypotension
|
4.2%
4/96 • Number of events 4
|
|
Cardiac disorders
Cardiogenic shock
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Inadvertent VT/VF
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/96 • Number of events 1
|
|
General disorders
General adverse reaction
|
8.3%
8/96 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
2/96 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
2.1%
2/96 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Post-surgical wound-discomfort
|
4.2%
4/96 • Number of events 4
|
|
Nervous system disorders
Phrenic nerve paralysis
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Low cardiac output
|
1.0%
1/96 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.0%
1/96 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic chest pain
|
1.0%
1/96 • Number of events 1
|
|
Blood and lymphatic system disorders
Peripheral vascular disease
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Multiple heart failure symptoms
|
7.3%
7/96 • Number of events 10
|
|
Gastrointestinal disorders
Gastrointestinal
|
6.2%
6/96 • Number of events 6
|
|
Cardiac disorders
Dyspnea
|
3.1%
3/96 • Number of events 3
|
|
Cardiac disorders
Heart failure symptoms-unspecified
|
4.2%
4/96 • Number of events 5
|
|
General disorders
Death
|
2.1%
2/96 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Atelactasis
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Impedance > 2000 Ohms-RV lead
|
1.0%
1/96 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
2.1%
2/96 • Number of events 2
|
|
Metabolism and nutrition disorders
Weight gain
|
2.1%
2/96 • Number of events 2
|
|
Cardiac disorders
Unable to capture- non RA lead related
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Syncope
|
1.0%
1/96 • Number of events 2
|
|
Cardiac disorders
Ventricular tachycardia
|
4.2%
4/96 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/96 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.0%
1/96 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematological
|
1.0%
1/96 • Number of events 1
|
|
Blood and lymphatic system disorders
Peripheral edema
|
3.1%
3/96 • Number of events 3
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
3/96 • Number of events 3
|
|
Renal and urinary disorders
Urosepsis
|
2.1%
2/96 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Chest pain-ischemic
|
1.0%
1/96 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Physical trauma
|
2.1%
2/96 • Number of events 2
|
|
Cardiac disorders
Dizziness
|
1.0%
1/96 • Number of events 1
|
|
Blood and lymphatic system disorders
Abnormal lab values
|
1.0%
1/96 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/96 • Number of events 2
|
|
Cardiac disorders
Ventricular fibrillation
|
1.0%
1/96 • Number of events 1
|
|
Cardiac disorders
Multi-system failure
|
3.1%
3/96 • Number of events 3
|
|
Endocrine disorders
Endocrine
|
2.1%
2/96 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
2.1%
2/96 • Number of events 3
|
|
Surgical and medical procedures
Tooth extraction
|
1.0%
1/96 • Number of events 2
|
|
Cardiac disorders
Aortic stenosis
|
1.0%
1/96 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombus
|
1.0%
1/96 • Number of events 1
|
|
Blood and lymphatic system disorders
Distal thromboemboli
|
1.0%
1/96 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary symtpoms
|
3.1%
3/96 • Number of events 4
|
Other adverse events
| Measure |
EASYTRAK EPI Implant Group
n=96 participants at risk
This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
|
|---|---|
|
General disorders
General adverse event
|
11.5%
11/96 • Number of events 14
|
|
Cardiac disorders
Atrial fibrillation
|
10.4%
10/96 • Number of events 12
|
|
Cardiac disorders
Extracardiac stimulation-LV lead
|
6.2%
6/96 • Number of events 8
|
|
Blood and lymphatic system disorders
Hypotension
|
5.2%
5/96 • Number of events 5
|
|
Cardiac disorders
Inappropriate tachy therapy
|
5.2%
5/96 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Post-surgical wound discomfort
|
6.2%
6/96 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary adverse events
|
6.2%
6/96 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER