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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUX-Dx PERFORM Study Enrollment | The first 227 subjects enrolled in the study belong to the "Safety Cohort". The number of subjects is required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects are not required to participate in the Holter study. Once the "Safety Cohort" enrollment is completed, all subsequent subjects are required to participate in the Holter study. All subjects who participate in the Holter study belong to the "Holter Cohort". |
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| Measure | Description | 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 |
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Inclusion Criteria:
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:
The following exclusion criteria are applicable for patients participating in the Holter study:
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Patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Northern Arizona Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42038683 | Derived | Richards M, Garner JB, Rogers JD, Mahajan D, Ravikumar V, Herrmann KL, Schwartz T, Okeson B, Kupfer ME, Stolen CM, Bavikati VV, Dukes JW, Manyam H, Pokorney SD; LUX-Dx PERFORM Investigators. Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study. Heart Rhythm O2. 2026 Feb 2;7(4):695-705. doi: 10.1016/j.hroo.2026.01.026. eCollection 2026 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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". |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2020 |
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| Flagstaff |
| Arizona |
| 86001 |
| United States |
| Arrythmia Research Group | Jonesboro | Arkansas | 72401 | United States |
| Scripps Memorial Hospital | La Jolla | California | 92037 | United States |
| Cardiology Associates Medical Group | Ventura | California | 93003 | United States |
| Cardiac Arrhythmia Service | Boca Raton | Florida | 33432 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| St. Luke's Idaho Cardiology Associates | Boise | Idaho | 83712 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Kansas City Arrhythmia Research LLC | Kansas City | Missouri | 66211 | United States |
| Cox Health | Springfield | Missouri | 65807 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Mount Sinai Morningside | New York | New York | 10025 | United States |
| North Carolina Heart and Vascular Research | Raleigh | North Carolina | 27607 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
| The Toledo Hospital | Toledo | Ohio | 43615 | United States |
| Presbyterian University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Monument Health Rapid City Hospital | Rapid City | South Dakota | 57701 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| PeaceHealth Southwest Medical | Vancouver | Washington | 98664 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Categories are not mutually exclusive. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ICM System-related Complication-free Rate at 30 Days Post-implant | 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. | Posted | Number | 97.5% Confidence Interval | Percentage of participants | 30 days |
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| Primary | ICM System-related Complication-free Rate at 12 Months Post-implant | 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. | Posted | Number | 97.5% Confidence Interval | Percentage of participants | 12 months |
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Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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". | 12 | 727 | 127 | 727 | 152 | 727 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1st Degree AV Block | Cardiac disorders | Systematic Assessment |
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| 2nd Degree AV Block | Cardiac disorders | Systematic Assessment |
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| 3rd Degree AV Block | Cardiac disorders | Systematic Assessment |
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| Abnormal Laboratory Values | General disorders | Systematic Assessment |
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| Atrial Fibrillation (AF) | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT) | Cardiac disorders | Systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebrovascular Accident (CVA) | Vascular disorders | Systematic Assessment |
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| Cerebrovascular accident (CVA) - ischemic | Vascular disorders | Systematic Assessment |
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| Chest Pain - Ischemic | Vascular disorders | Systematic Assessment |
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| Chest Pain - Other | General disorders | Systematic Assessment |
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| Coronary Artery Disease | Vascular disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Dehydration - Heart Failure | Cardiac disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Edema | Vascular disorders | Systematic Assessment |
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| Endocrine | Endocrine disorders | Systematic Assessment |
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| Fatigue/Weakness | General disorders | Systematic Assessment |
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| Fever and/or Virus | Infections and infestations | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| Head, eyes, ears, nose, throat (HEENT) | General disorders | Systematic Assessment |
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| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypertension/Hypertensive Crisis | Vascular disorders | Systematic Assessment |
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| Localized Infection | Infections and infestations | Systematic Assessment |
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| Multiple Heart Failure Symptoms | Cardiac disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myocardial Infarction | Vascular disorders | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Nonsustained ventricular tachycardia (NSVT) | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion - unrelated procedure/device | Cardiac disorders | Systematic Assessment |
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| Physical Trauma | General disorders | Systematic Assessment |
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| Pleural Effusion - Heart Failure | Cardiac disorders | Systematic Assessment |
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| Pneumothorax - unrelated procedure/device | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Post Surgical wound discomfort/bruising/swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
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| Syncope | General disorders | Systematic Assessment |
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| System Infection | Infections and infestations | Systematic Assessment |
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| Transient Ischemic Attack (TIA) | Vascular disorders | Systematic Assessment |
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| Ventricular Fibrillation (VF) | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia (VT)/Monomorphic VT | Cardiac disorders | Systematic Assessment |
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| Dislodgement - Unable to capture - RV | Product Issues | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 2nd Degree AV Block | Cardiac disorders | Systematic Assessment |
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| 3rd Degree AV Block | Cardiac disorders | Systematic Assessment |
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| Adverse Reaction - other | Injury, poisoning and procedural complications | Systematic Assessment |
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| Atrial Fibrillation (AF) | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT) | Cardiac disorders | Systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest Pain - Heart Failure | Cardiac disorders | Systematic Assessment |
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| Chest Pain - Other | General disorders | Systematic Assessment |
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| Coronary Artery Disease | Vascular disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea - Heart Failure | Cardiac disorders | Systematic Assessment |
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| Erosion | Product Issues | Systematic Assessment |
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| Head, eyes, ears, nose, throat (HEENT) | General disorders | Systematic Assessment |
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| Hypertension/Hypertensive Crisis | Vascular disorders | Systematic Assessment |
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| Hypotension/Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
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| Infection (> 30 days post implant) | Infections and infestations | Systematic Assessment |
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| Integumentary | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Intracardiac thrombus | Cardiac disorders | Systematic Assessment |
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| Multiple Heart Failure Symptoms | Cardiac disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Nonsustained ventricular tachycardia (NSVT) | Cardiac disorders | Systematic Assessment |
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| Other - ICM System | Product Issues | Systematic Assessment |
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| PG System - Patient Related - OTHER | Injury, poisoning and procedural complications | Systematic Assessment |
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| Patient Condition - Cardiovascular - OTHER | Cardiac disorders | Systematic Assessment |
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| Peripheral Vascular Disease | Vascular disorders | Systematic Assessment |
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| Post Surgical wound discomfort/bruising/swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post -Surgical infection ( 30 days post implant) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-surgical pocket hemorrhage/bleeding/drainage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Premature Ventricular Contractions (PVC) | Cardiac disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
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| Syncope | General disorders | Systematic Assessment |
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| Transient Ischemic Attack (TIA) | Vascular disorders | Systematic Assessment |
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| Ventricular Tachycardia (VT)/Monomorphic VT | Cardiac disorders | Systematic Assessment |
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| Whole Body - OTHER | General disorders | Systematic Assessment |
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| Device Expulsion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Stoltz, Clinical Trial Manager | Boston Scientific | 1-800-CARDIAC | thomas.stoltz@bsci.com |
| Apr 1, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013575 | Syncope |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or other Pacific Islander |
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| Race - Other |
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| Not disclosed |
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| Ethnicity Hispanic or Latino - Mexican |
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| Ethnicity Hispanic or Latino - Puerto Rican |
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| Ethnicity Hispanic or Latino - Other |
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