N/A
Completed N=210
Evaluation of Automatic Threshold Algorithms
Source: ClinicalTrials.gov NCT02097290 ↗Enrolled (actual)
210
Serious AEs
48.1%
Results posted
Sep 2017
Primary outcomePrimary: Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate — 84.2 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate |
84.2 | — |
| 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. |
97.9 | — |
| 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. |
97.8 | — |
| 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 |
99.0 | — |
| 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 |
97.7 | — |
| SECONDARY RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome |
85.4 | — |
| SECONDARY LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome |
95.1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
- Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
- Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
- 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
- Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law
Exclusion Criteria
- Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
- Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
- 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
- Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
- Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
- Subjects with a RV or LV lead revision or extraction within 30 days of enrollment
- Subjects with an implanted lead that is planned to be extracted during the study implant procedure
- Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
- Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
- Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
- Subjects with a life expectancy less than 6 months
- Subjects with a prosthetic mechanical tricuspid heart valve
- 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
- 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
- Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center
Data sourced from ClinicalTrials.gov (NCT02097290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.