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The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients.
In the QLV arm the physician will:
In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLV based implant strategy | Experimental | QLV represents the pacing site with the largest amount of dyssynchrony as measured by the left ventricular electrical delay. The QLV based implant strategy finds the left ventricle vein branch and left ventricular lead cathode with the longest QLV measurement and places the lead at this location and programs the device using this lead cathode. |
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| Standard of care implant strategy | Placebo Comparator | The placement of LV lead will be carried out according to the physician's standard of care implant approach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLV based implant strategy | Device |
| ||
| Standard of care implant strategy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Improved Clinical Composite Score | Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. | 12 months |
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Inclusion Criteria:
Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration ≥ 120ms)
Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines:
Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing
Are 18 years or older, or of legal age to give informed consent specific to state and local law
Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jagmeet Singh, MD, PhD | Massachusetts General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States | ||
| USC University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30264456 | Background | Singh JP, Berger RD, Doshi RN, Lloyd M, Moore D, Daoud EG; ENHANCE CRT Study Group. Rationale and design for ENHANCE CRT: QLV implant strategy for non-left bundle branch block patients. ESC Heart Fail. 2018 Dec;5(6):1184-1190. doi: 10.1002/ehf2.12340. Epub 2018 Sep 27. |
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The study enrolled 248 subjects, with 247 having an attempted implant. Of the 247 subjects with an attempted implant, three subjects were excluded from analysis based on having a LBBB morphology and two excluded based on QRS duration <120 ms.
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| ID | Title | Description |
|---|---|---|
| FG000 | QLV Study Arm | The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle. |
| FG001 | Standard of Care Study Arm |
| 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_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 19, 2013 |
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| Device |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| Mission Hospital | Mission Viejo | California | 92691 | United States |
| St. Joseph's Medical Center | Stockton | California | 95204 | United States |
| Baker-Gilmour Cardiovascular Institute | Jacksonville | Florida | 32216 | United States |
| Northside Hospital | St. Petersburg | Florida | 33709 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Atlanta Heart Associates - Riverdale | Riverdale | Georgia | 30274 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Oschner Medical Center | New Orleans | Louisiana | 70448 | United States |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| McLaren Macomb | Mount Clemens | Michigan | 48043 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Bryan LGH Heart Institute | Lincoln | Nebraska | 68506 | United States |
| Northshore University Hospital | Manhasset | New York | 11030 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11790 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Sutherland Cardiology Clinic | Germantown | Tennessee | 38138 | United States |
| Cardiovascular Associates, PC | Kingsport | Tennessee | 37660 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Baylor Regional Center at Plano | Plano | Texas | 75093 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Lynchburg General Hospital | Lynchburg | Virginia | 24501 | United States |
| Cardiovascular Associates of Virginia | Midlothian | Virginia | 23224 | United States |
The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach.
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| NOT COMPLETED |
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The study enrolled 248 subjects, with 247 having an attempted implant. Of the 247 subjects with an attempted implant, three subjects presented with a LBBB morphology and two with QRS durations <120 ms. Therefore, a total of 242 subjects are included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | QLV Study Arm | The QLV study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the site of latest electrical delay within the left ventricle. |
| BG001 | Standard of Care Study Arm | The Standard of Care study arm includes those patients randomized to receive the placement of the left ventricular CRT lead based on the investigator's standard of care implant approach. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations <120 ms. | Mean | Standard Deviation | years |
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| Sex: Female, Male | The study enrolled 248 subjects, 247 having an attempted implant. Three subjects presented with a LBBB morphology and two with QRS durations <120 ms. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| NYHA Classification | New York Heart Association (NYHA) functional classification has 4 categories: Class I (least severe) : No limitation of physical activity Class II: Slight limitation of physical activity Class III: Marked limitation of physical activity Class IV (most severe): Unable to carry on any physical activity without discomfort | Count of Participants | Participants |
| |||||||||||||||
| Type of Cardiomyopathy | Count of Participants | Participants |
| ||||||||||||||||
| Types of QRS Morphology | Type of QRS complex morphology was assessed by investigators based on 12-lead ECGs acquired.The QRS complex is typically the main spike seen on an ECG and represents the depolarization of the ventricles of the heart. Main criteria used to assess morphology are athe width and height of the QS complex along with certain patterns. | Count of Participants | Participants |
| |||||||||||||||
| QRS Duration | QRS duration is the width of the QRS complex usually measured in milliseconds. | 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 | Number of Patients With Improved Clinical Composite Score | Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. | Of the 242 subjects enrolled, 44 withdrew for reasons other than cardiac death, six had a missing 12-month visit for reasons other than a heart failure event and two had missing Patient Global Assessments or NYHA classification assessments. As a result, the primary endpoint analysis included 190 enrolled subjects (128 QLV arm; 62 control arm). | Posted | Count of Participants | Participants | 12 months |
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Adverse Events were collected over a time period of 1 year from enrollment
Adverse events are any unfavorable clinical event which impacts, or has the potential to impact the health or safety of a patient caused by or associated with a study device or intervention. Adverse events are classified as complication or observations.
Complications: Adverse events that require invasive intervention.
Observations: Adverse events that can be managed without invasive intervention.
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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 | Standard of Care | In the control arm, investigators implanted the LV lead without the use of QLV measurements and instead used standard practices to identify the most suitable LV lead location | 4 | 62 | 4 | 62 | 14 | 62 |
| EG001 | QLV Based Lead Implant | In the QLV arm, the implanting physician assessed the QLV in at least two main branches of the coronary sinus for LV lead placement | 9 | 128 | 8 | 128 | 31 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cardiac Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lead Dislodgement Or Migration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
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| Atrial Or Ventricular Arrhythmia | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cardiac Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Coronary Sinus Dissection | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lead Fracture | Product Issues | Systematic Assessment |
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| Therapy For Non-Ventricular Rhythm | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Or Ventricular Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Bleeding/Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Elevated Pacing Thresholds | Product Issues | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Local Tissue Reaction; Formation Of Fibrotic Tissue | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Loss Of Capture | Product Issues | Systematic Assessment |
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| Oversensing | Product Issues | Systematic Assessment |
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| Phrenic Nerve/Diaphragmatic Stimulation | Product Issues | Systematic Assessment |
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| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rise In Threshold And Exit Block | Product Issues | Systematic Assessment |
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| Undersensing | Product Issues | Systematic Assessment |
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| Other: Back Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Decompensated Systolic Heart Failure | Cardiac disorders | Systematic Assessment |
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| Other: Desaturation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Device Insertion Site Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Device Insertion Site Pain (Intermittent) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Device Reset To Back Up Vvi | Product Issues | Systematic Assessment |
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| Other: Device Site Burning (Intermittent) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Device Site Numbness | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Device Site Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Device Site Redness | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Diaphragm Stimulation While Lying Supine | Product Issues | Systematic Assessment |
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| Other: Dysphagia | General disorders | Systematic Assessment |
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| Other: Dysphagia And Dysguesia | General disorders | Systematic Assessment |
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| Other: Elevated Lv Capture Threshold | Product Issues | Systematic Assessment |
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| Other: Itching | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Left Clavicle Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Left Shoulder Discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Left Shoulder Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Left Upper Extremity Edema | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Other: Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Respiratory Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other: Swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other: Worsening Heart Failure Due To Crt | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn | Abbott | 1 972 309 8087 | clay.cohorn@abbott.com |
| Feb 14, 2019 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| NYHA III |
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| NYHA IV |
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| Non-ischemic |
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| None |
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| Right Bundle Branch Block |
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| Right Bundle Branch/Left Anterior Fascicular Block |
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| Right Bundle/Left Posterior Fascicular Block |
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| Other |
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| >= 150 msec |
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