Heart Failure
Conditions
Keywords
Threshold algorithms, CRT-D
Brief summary
This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices.
Detailed description
The objective of the CAPTIVATE Clinical Study is to gather data to establish the safety and effectiveness of the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features to support the regulatory approval of the AUTOGEN CRT-D family of devices.
Interventions
DEVICECRT-D
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
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
1. Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173 2. Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead 3. Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead 4. Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol 5. Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law
Exclusion criteria
1. Subjects who have an implanted multipolar (\>2poles) left ventricular lead or who will receive a multipolar (\>2poles) left ventricular lead 2. Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead 3. Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned 4. Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949 5. Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T 6. Subjects with a RV or LV lead revision or extraction within 30 days of enrollment 7. Subjects with an implanted lead that is planned to be extracted during the study implant procedure 8. Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned 9. Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned 10. Subjects preexisting unipolar pacemaker that will not be explanted/abandoned 11. Subjects with a life expectancy less than 6 months 12. Subjects with a prosthetic mechanical tricuspid heart valve 13. Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time 14. Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific 15. Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold. | 1-month and 3-month follow-up visits | Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: \|commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. |
| The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold | 1-month and 3-month follow up visits | Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:\|Ambulatory threshold - ECG threshold\| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V; if the ECG threshold is \> 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis. |
| The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold | 1-month and 3-month follow up visits | Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis. |
| Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate | 3 months | Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead. |
| The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold. | 1-month and 3-month follow up visits | Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome | 3-month follow up visit | This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: 1. A device-determined threshold 2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests 3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above. |
| RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome | 3-month follow up visit | This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: 1. A device-determined threshold 2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests 3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRT-D For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated | 210 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Attempt | 8 |
| Overall Study | Death | 6 |
| Overall Study | Total Withdrawals | 3 |
Baseline characteristics
| Characteristic | CRT-D |
|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 10.8 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 25 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 8 Participants |
| Race/Ethnicity, Customized Multiple Races | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Undisclosed | 2 Participants |
| Race/Ethnicity, Customized White | 170 Participants |
| Region of Enrollment United States | 210 Participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 210 |
| other Total, other adverse events | 81 / 210 |
| serious Total, serious adverse events | 101 / 210 |
Outcome results
Primary
Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
Time frame: 3 months
Population: Implant + Attempt Subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D | Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate | 84.2 Percentage of participants |
Primary
The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Time frame: 1-month and 3-month follow up visits
Population: A total of 300 paired datasets (from 175 unique subjects in whom LVAT threshold was available), each dataset consisting of a ambulatory LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D | The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold | 97.7 Percentage of accurate threshold |
Primary
The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Time frame: 1-month and 3-month follow up visits
Population: A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D | The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold. | 97.8 Percentage of commanded LVAT thresholds |
Primary
The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:\|Ambulatory threshold - ECG threshold\| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V; if the ECG threshold is \> 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Time frame: 1-month and 3-month follow up visits
Population: A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D | The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold | 99.0 Percentage of RVAT ambulatory thresholds |
Primary
The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: \|commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Time frame: 1-month and 3-month follow-up visits
Population: A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D | The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold. | 97.9 percentage of commanded RVAT thresholds |
Secondary
LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: 1. A device-determined threshold 2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests 3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.
Time frame: 3-month follow up visit
Population: A total of 182 unique subjects in whom a paired LVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an LVAT threshold test outcome and core lab determined threshold test outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D | LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome | 95.1 percentage of appropriate outcome |
Secondary
RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: 1. A device-determined threshold 2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests 3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.
Time frame: 3-month follow up visit
Population: A total of 157 unique subjects in whom a paired RVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an RVAT threshold test outcome and core lab determined threshold test outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D | RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome | 85.4 percentage of appropriate outcome |