Atrial Fibrillation, Cryptogenic Stroke, Syncope
Conditions
Brief summary
The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM) device and (2) to collect data to characterize the performance of arrhythmia detection algorithms. Data was also collected to characterize the ICM system related safety events.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient is indicated to be implanted with the LUX-Dx ICM for one of the following reasons (grouped in three Reason for Monitoring subgroups): 1) Cryptogenic stroke, 2) Syncope, 3) AF management, Post-AF ablation, or Suspected AF * Patient is willing to enroll and be monitored in LATITUDE Clarity. * Patient is willing and able to be followed remotely via the ICM patient mobile app. * Patient is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and agrees to participate in all protocol required activities. * Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law. The following inclusion criterion is applicable for patients participating in the Holter study: • Patient can tolerate the adhesive used in the Holter monitoring for an extended period of time.
Exclusion criteria
* Patient is indicated for implantation of, or is currently implanted with an active implantable cardiac device (e.g., LVAD, ICD, CRT D, PPM\*). * Patient cannot tolerate a subcutaneous, chronically-inserted device due to medical condition. * Patient has a documented life expectancy of less than 12 months (per investigator's discretion). * Patient is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion). * Patient is currently enrolled in another clinical study including observational studies/registries, unless prior written approval from BSC is obtained. Mandatory governmental registries are accepted for co-enrollment without approval by BSC. The following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICM System-related Complication-free Rate at 30 Days Post-implant | 30 days |
| ICM System-related Complication-free Rate at 12 Months Post-implant | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LUX-Dx PERFORM Study Enrollment The first 227 subjects enrolled in the study belonged to the Safety Cohort. The number of subjects was required to fulfill the sample size requirement of the primary safety endpoint. The Safety Cohort subjects were not required to participate in the Holter study. Once the Safety Cohort enrollment was completed, all subsequent subjects were required to participate in the Holter study. All subjects who participated in the Holter study belong to the Holter Cohort. | 727 |
| Total | 727 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 12 |
| Overall Study | Withdrawn | 136 |
Baseline characteristics
| Characteristic | LUX-Dx PERFORM Study Enrollment |
|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 13.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 60 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino - Mexican | 15 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino - Other | 11 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino - Puerto Rican | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Not disclosed | 27 Participants |
| Race/Ethnicity, Customized Race - Other | 2 Participants |
| Race/Ethnicity, Customized White | 634 Participants |
| Sex: Female, Male Female | 372 Participants |
| Sex: Female, Male Male | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 727 |
| other Total, other adverse events | 152 / 727 |
| serious Total, serious adverse events | 127 / 727 |
Outcome results
Primary
ICM System-related Complication-free Rate at 12 Months Post-implant
Time frame: 12 months
Population: The chronic primary safety endpoint was the LUX-Dx ICM system-related CFR at 12 months post-implant where the ICM system refers to the LUX-Dx ICM device, mobile applications, and the associated accessories used with the device. All implants and attempts with a de novo ICM are included in the at-risk group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LUX-Dx PERFORM Study Enrollment | ICM System-related Complication-free Rate at 12 Months Post-implant | 99.6 Percentage of participants |
Primary
ICM System-related Complication-free Rate at 30 Days Post-implant
Time frame: 30 days
Population: The acute primary safety endpoint was the LUX-Dx ICM system-related CFR at 30 days post-implant where the ICM system refers to the LUX-Dx ICM device, mobile applications, and the associated accessories used with the device. All implants and attempts with a de novo ICM are included in the at-risk group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LUX-Dx PERFORM Study Enrollment | ICM System-related Complication-free Rate at 30 Days Post-implant | 99.9 Percentage of participants |