Bradycardia, Congestive Heart Failure
Conditions
Keywords
Artificial Cardiac Pacing, Implanted Electrodes
Brief summary
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Detailed description
This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.
Interventions
DEVICEEASYTRAK EPI lead
EASYTRAK EPI lead
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who meet the EASYTRAK EPI indications * Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law * Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol * Patients who meet any one of the following three conditions: * Meet current indications for cardiac resynchronization therapy (CRT) and epicardial placement of a pace/sense lead on the left ventricle is preferred over an endocardial lead * Meet current indications for a cardiac pacing system and have documented evidence that an endocardial lead cannot be used * Meet current indications for a cardiac pacing system and a concurrent cardiac surgical procedure is taking place where no additional surgical procedures are required to provide access to the epicardial surface of the heart
Exclusion criteria
* Patients who meet the EASYTRAK EPI contraindications * Patients who have had a myocardial infarct, unstable angina, or percutaneous coronary intervention during the preceding 30 days prior to enrollment * Patients with a documented life expectancy of less than 6 months or expected to undergo heart transplant within the next 6 months * Patients enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study * Women who are pregnant or plan to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pacing Thresholds at 3 Months | 3 months | The expected mean pacing threshold is 1.9V at 0.5 ms pulse width. |
| Chronic Pacing Impedances at 3 Months | 3 months | The expected mean impedance is 500 Ohms. |
| Chronic Sensing Amplitudes at 3 Months | 3 months | The expected mean is 10mV. |
| Lead-related Complication-free Rate at 3 Months | 3 months | The estimated target value for this endpoint is 80%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lead Implant Time | Implant | The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EASYTRAK EPI Lead Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.
EASYTRAK EPI lead: EASYTRAK EPI lead | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | EASYTRAK EPI Lead |
|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment Canada | 1 Participants |
| Region of Enrollment Sweden | 7 Participants |
| Region of Enrollment United States | 88 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 96 |
| other Total, other adverse events | 49 / 96 |
| serious Total, serious adverse events | 55 / 96 |
Outcome results
Primary
Chronic Pacing Impedances at 3 Months
The expected mean impedance is 500 Ohms.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EASYTRAK EPI Implant Group | Chronic Pacing Impedances at 3 Months | 500 Ohms | Standard Deviation 137 |
Primary
Chronic Pacing Thresholds at 3 Months
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EASYTRAK EPI Implant Group | Chronic Pacing Thresholds at 3 Months | 0.9 V | Standard Deviation 0.5 |
Primary
Chronic Sensing Amplitudes at 3 Months
The expected mean is 10mV.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EASYTRAK EPI Implant Group | Chronic Sensing Amplitudes at 3 Months | 15.8 mV | Standard Deviation 7.2 |
Primary
Lead-related Complication-free Rate at 3 Months
The estimated target value for this endpoint is 80%.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EASYTRAK EPI Implant Group | Lead-related Complication-free Rate at 3 Months | 97.9 % of complication free-rate |
Secondary
Lead Implant Time
The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.
Time frame: Implant
Population: Although 96 subjects were implanted/attempted, lead implant time was only collected for 69 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EASYTRAK EPI Implant Group | Lead Implant Time | 1.47 h.min | Standard Deviation 1.05 |