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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death
While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for sudden death prevention in high risk individuals, reduction of device associated morbidity remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown modest benefits of atrial pacing in preventing atrial fibrillation, however right ventricular (RV) pacing was not limited, thus any favorable effects associated with atrial prevention and treatment may have been offset by the RV pacing. New algorithms to prevent RV pacing are now made available in our current devices. The choice of dual chamber versus single chamber ICD for primary prevention warrants re-assessment of atrial prevention and termination therapies, without the potentially adverse effects of RV pacing.
This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50 to dual chamber ICDs. Patients will be followed for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Chamber ICD | Active Comparator | Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation. |
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| Single Chamber ICD | Active Comparator | Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies will be programmed on including use of detection enhancements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Chamber ICD | Device | Dual Chamber ICD: Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation Dual Chamber ICD Atrial prevention and termination therapies, Managed Ventricular Pacing (MVP)along with VT/VF detection and therapies for dual chamber device. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) | An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation). | Baseline to 12 months after ICD implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes | Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes. | Baseline to 12 Months |
| Number of Appropriate Shocks by ICD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Friedman, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | United States | |||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11232608 | Background | Deisenhofer I, Kolb C, Ndrepepa G, Schreieck J, Karch M, Schmieder S, Zrenner B, Schmitt C. Do current dual chamber cardioverter defibrillators have advantages over conventional single chamber cardioverter defibrillators in reducing inappropriate therapies? A randomized, prospective study. J Cardiovasc Electrophysiol. 2001 Feb;12(2):134-42. doi: 10.1046/j.1540-8167.2001.00134.x. | |
| 16769912 |
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From 2008 to 2010, patients who were undergoing Implantable Cardioverter-Defibrillators (ICD) device implantation at Mayo Clinic in Rochester, Minnesota and Jacksonville, Florida and at two Israeli medical center sites, Sheba Medical Center in Ramat Gan and Carmel Medical Center in Haifa, were screened for entry into this open-label study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dual Chamber ICD | Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Single Chamber ICD | Device | Single Chamber: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. VT/VF detection and therapies with discrimination criteria for single chamber device. |
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Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm. |
| Baseline to 12 Months |
| Total Cost of ICD Implantation Procedure | Baseline |
| Number of Subjects With Newly Detected Atrial Tachyarrhythmias | Baseline to 12 months after ICD implantation |
| Atrial Fibrillation (AF) Burden | AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value. | Implantation through 1 year |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Carmel Medical Center | Haifa | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Background |
| Friedman PA, McClelland RL, Bamlet WR, Acosta H, Kessler D, Munger TM, Kavesh NG, Wood M, Daoud E, Massumi A, Schuger C, Shorofsky S, Wilkoff B, Glikson M. Dual-chamber versus single-chamber detection enhancements for implantable defibrillator rhythm diagnosis: the detect supraventricular tachycardia study. Circulation. 2006 Jun 27;113(25):2871-9. doi: 10.1161/CIRCULATIONAHA.105.594531. Epub 2006 Jun 12. |
| 17445918 | Background | Theuns DA, Rivero-Ayerza M, Boersma E, Jordaens L. Prevention of inappropriate therapy in implantable defibrillators: A meta-analysis of clinical trials comparing single-chamber and dual-chamber arrhythmia discrimination algorithms. Int J Cardiol. 2008 Apr 25;125(3):352-7. doi: 10.1016/j.ijcard.2007.02.041. Epub 2007 Apr 18. |
| 17804844 | Background | Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, Sheldon T, Lamas GA; Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. 2007 Sep 6;357(10):1000-8. doi: 10.1056/NEJMoa071880. |
| 24928948 | Background | Friedman PA, Bradley D, Koestler C, Slusser J, Hodge D, Bailey K, Kusumoto F, Munger TM, Militanu A, Glikson M. A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in primary sudden cardiac death prevention. Europace. 2014 Oct;16(10):1460-8. doi: 10.1093/europace/euu022. Epub 2014 Jun 13. |
| FG001 |
| Single Chamber ICD |
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dual Chamber ICD | Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation. |
| BG001 | Single Chamber ICD | Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Date of birth not obtained for 4 Israeli subjects (treatment arm unknown). | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| NYHA Classification | New York Heart Association (NYHA) classification of Heart Failure is used to describe the degree of limitation due to heart failure at baseline. I. No limitation, II. Limitation with ordinary activity, III. Limitation with less than daily activity, IV. Symptoms at rest, (NA-Not applicable; participants without heart failure) | Number | Participants |
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| LV Ejection Fraction | Left ventricular Ejection Fraction (LVEF) is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a calculated measure of the amount of blood pumped out of the lower chamber of the heart during a heartbeat, measured using echocardiography. A normal LVEF ranges from 55-70%. A LVEF of 65, for example, means that 65% of the total amount of blood in the left ventricle is pumped out with each heartbeat. Note: LVEF baseline data is missing for one Israeli subject, arm unknown. | Mean | Standard Deviation | Percentage of LV blood volume |
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| Co-morbidities | Participants could have had more than one co-morbidity, therefore the sum total of co-morbid conditions will not equal the total number of participants. | Number | participants |
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| Cardiac Disease | Participants could have more than one concomitant cardiac disease event/diagnosis, therefore the sum total of all cardiac conditions will not equal the total number of participants. | Number | Participants |
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| Concomitant Medications | Each category lists the number of participants taking each medication. | Number | Participants |
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| Ventricular Depolarization (QRS) Duration | Note:QRS baseline data is missing for one Israeli subject. As the heart undergoes depolarization and repolarization, the electrical currents that are generated spread within the heart & throughout the body. This electrical activity can be measured by electrodes placed on the body surface & produce a tracing called an electrocardiogram (ECG, or EKG). The different waves that comprise the ECG represent the sequence of depolarization and repolarization of the atria and ventricles. Certain points on the ECG tracing are assigned letters. The QRS complex represents ventricular depolarization. | Mean | Standard Deviation | milliseconds |
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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 Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) | An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation). | Intent to Treat population analyzed. | Posted | Number | Participants | Baseline to 12 months after ICD implantation |
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| Secondary | Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes | Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes. | Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm). | Posted | Number | Episodes | Baseline to 12 Months |
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| Secondary | Number of Appropriate Shocks by ICD | Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm. | Intent to Treat population analyzed. | Posted | Number | Shocks | Baseline to 12 Months |
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| Secondary | Total Cost of ICD Implantation Procedure | Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs. | Posted | Mean | Standard Deviation | US Dollars | Baseline |
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| Secondary | Number of Subjects With Newly Detected Atrial Tachyarrhythmias | Intent to Treat population analyzed. | Posted | Number | Participants | Baseline to 12 months after ICD implantation |
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| Secondary | Atrial Fibrillation (AF) Burden | AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value. | Intent to treat analysis population. | Posted | Mean | Standard Deviation | Percentage of atrial arrhythmias per min | Implantation through 1 year |
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Implantation of ICD to one year.
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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 | Dual Chamber ICD | Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation. | 8 | 50 | 16 | 50 | ||
| EG001 | Single Chamber ICD | Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. | 8 | 50 | 5 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | The cause of death for two Israeli subjects was not reported. |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Cancer spreading | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Chest Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Defibrillator Threshold testing could not be done at implant | Surgical and medical procedures | Systematic Assessment |
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| Difficulty Breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fluid overload | Cardiac disorders | Systematic Assessment |
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| High Blood Pressure | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Right ventricular lead replaced | Surgical and medical procedures | Systematic Assessment |
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| Syncope | Cardiac disorders | Systematic Assessment |
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| Venous thromboembolism | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma/Seroma | Vascular disorders | Systematic Assessment |
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| Infection/Erosion | Infections and infestations | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Pneumothorax/Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Phlebitis/Thrombosis/Embolism | Vascular disorders | Systematic Assessment |
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| Cerebrovascular Accident/Transient Ischemic Attack | Vascular disorders | Systematic Assessment |
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| Device dislodgement from ventricle | Injury, poisoning and procedural complications | Systematic Assessment |
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| Device Oversensing-Atrial | Surgical and medical procedures | Systematic Assessment |
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| Device Oversensing-Ventricle | Surgical and medical procedures | Systematic Assessment |
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| Device Failure to Capture-Atrial | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul A. Friedman, MD, Professor of Medicine | Mayo Clinic | 507-284-7661 | friedman.paul@mayo.edu |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D001281 | Atrial Fibrillation |
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Israel |
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| II- Limitation with ordinary activity |
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| III-Limitation with less than daily activity |
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| IV-Symptoms at rest |
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| NA-No heart failure |
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| Heart Failure present but NYHA class not recorded |
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| Diabetes |
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| Hypertension |
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| Hyperlipidemia |
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| Stroke |
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| Transient Ischemic Attack |
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| History of Paroxysmal Atrial Fibrillation |
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| Myocardial Infarction |
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| Percutaneous Coronary Intervention |
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| Coronary Artery Bypass Graft |
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| Hypertrophic Cardiomyopathy |
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| Dilated Cardiomyopathy |
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| Calcium Channel Blocker |
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| Amiodarone |
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