Heart Failure
Conditions
Keywords
Heart Failure, Cardiac Resynchronization Therapy (CRT), CRT-D, Quadripolar pacing
Brief summary
The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted with/scheduled to receive a commercially available quadripolar left ventricular lead * Subject is willing and capable of providing informed consent and participating in all testing and study visits associated with this investigation at an approved center and at the intervals defined by this protocol * Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
* Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) * Subject is enrolled in any other concurrent study, without prior approval from BSC * Women of childbearing potential who are or might be pregnant at the time of study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Vectors With Phrenic Nerve Stimulation (PNS) | Pre-discharge (up to 7 days post implant) | The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final Pacing Treshold at Pre-discharge | Pre-discharge (up to 7 days post implant) | Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. |
| Final LV Lead Impedance at Pre-discharge | Pre-discharge (up to 7 days post implant) | Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. |
| Final Sensing Amplitude at Pre-discharge | Pre-discharge (up to 7 days post implant) | Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice. |
| Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | At time of implantation (0 to 30 days post consent signature) | Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate. |
Countries
United States
Participant flow
Pre-assignment details
A total of 749 subjects were enrolled. Of these, 7 did not complete baseline demographics due to early withdrawals and 1 additional was withdrawn due to LV lead not placed. Therefore, baseline demographics is based on a maximum of 742 subjects.
Participants by arm
| Arm | Count |
|---|---|
| All Study Patients All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance. | 742 |
| Total | 742 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Device implant unsuccessful | 53 |
| Overall Study | Investigator withdrawal | 10 |
| Overall Study | not disclosed by site | 7 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | All Study Patients | — |
|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 10.3 | — |
| Left Ventricular Ejection Fraction (LVEF) % | 26.5 % STANDARD_DEVIATION 8.3 | — |
| QRS width | 153.7 ms STANDARD_DEVIATION 28.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 742 Participants | — |
| Sex: Female, Male Female | 180 Participants | — |
| Sex: Female, Male Male | 562 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 749 |
| other Total, other adverse events | 11 / 749 |
| serious Total, serious adverse events | 16 / 749 |
Outcome results
Primary
Number of Vectors With Phrenic Nerve Stimulation (PNS)
The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.
Time frame: Pre-discharge (up to 7 days post implant)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Patients | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Unique pacing vectors with PNS | 181 Number of Pacing vectors with PNS |
| All Study Patients | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Common vectors with PNS | 189 Number of Pacing vectors with PNS |
Secondary
Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.
Time frame: At time of implantation (0 to 30 days post consent signature)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Patients | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Skin to skin time (min) | 82.4 Minutes | Standard Deviation 38.9 |
| All Study Patients | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Lead placement time (min) | 24.5 Minutes | Standard Deviation 23.5 |
| All Study Patients | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | CS Canulation Time (min) | 6.2 Minutes | Standard Deviation 9.4 |
| All Study Patients | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Overall catheter in the body time (min) | 25.9 Minutes | Standard Deviation 21.8 |
| Other LV Lead Delivery Systems | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Overall catheter in the body time (min) | 32.7 Minutes | Standard Deviation 25.1 |
| Other LV Lead Delivery Systems | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Skin to skin time (min) | 87.8 Minutes | Standard Deviation 38.9 |
| Other LV Lead Delivery Systems | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | CS Canulation Time (min) | 7.8 Minutes | Standard Deviation 12.2 |
| Other LV Lead Delivery Systems | Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems | Lead placement time (min) | 29.8 Minutes | Standard Deviation 24.8 |
Secondary
Final LV Lead Impedance at Pre-discharge
Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Time frame: Pre-discharge (up to 7 days post implant)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Patients | Final LV Lead Impedance at Pre-discharge | 1034.7 Ohms | Standard Deviation 310.6 |
Secondary
Final Pacing Treshold at Pre-discharge
Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Time frame: Pre-discharge (up to 7 days post implant)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Patients | Final Pacing Treshold at Pre-discharge | 1.93 Volts | Standard Deviation 1.87 |
Secondary
Final Sensing Amplitude at Pre-discharge
Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Time frame: Pre-discharge (up to 7 days post implant)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Patients | Final Sensing Amplitude at Pre-discharge | 13.30 Milivolts | Standard Deviation 6.4 |