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The mean follow-up during Randomized Access was 17.6 months for a total duration of 
approximately 800 patient years.  During the course of Randomized Access, 93 patients 
in the Treatment group and 110 patients in the Control group exited the study with the 
primary reason being death.  
 
A total of 347 patients (177 in the Treatment group and 170 in the Control group) 
completed Randomized Access and entered Open Access.  The mean follow-up during 
Open Access was 13 months for a total duration of approximately 400 patient years.  
During the course of Open Access, 58 patients in the Treatment group and 43 patients in 
the Control group exited the study with the primary reason being death.     

 
 

Primary and Secondary Endpoint Results 

Primary Safety Endpoints 

The CHAMPION clinical trial met the two primary safety endpoints: (1) Freedom from 
device/system related complications (DSRC) and (2) Freedom from sensor failure. The 
protocol pre-specified objective performance criteria (OPC) were that at least 80% of 
patients were to be free from DSRC and at least 90% were to be free from pressure 
sensor failure. Of the 575 patients in the safety population, 567 (98.6%) were free from 
DSRC at 6 months (lower confidence limit 97.3%, p<0.0001). This lower limit of 97.3% is 
greater than the pre-specified OPC of 80% (Table 6a and 6b). There were no sensor 
explants or repeat implants and all sensors were operational at 6 months for a freedom 
from sensor failure of 100% (lower confidence limit 99.3%, p<0.0001). This lower limit of 
99.3% is greater than the pre-specified OPC of 90% (Table 7).   

 
Table 6a. Primary Safety Endpoint – Freedom from Device/System Related Complications 

Device/System Related 

Complications (n=575) 

Lower 95.2% 

Confidence 

Limit

2

 

Objective Performance 

Criterion (OPC) 

p-value

3

 

Yes 

No 

 

 

 

8 (1.4%)

1

 

567 (98.6%) 

97.3% 

80% 

p<0.0001 

1 

DSRCs (8 total) by group: Consented but not randomized (2), Treatment (3), Control (3) 

2

 Exact 95.2% Clopper-Pearson lower confidence limit 

3

 p-value from exact test of binomial proportions compared to 80% for all patients

 

 
Table 6b. Primary Safety Endpoint – Description of Device/System Related Complications 

Description 

 

Number of Subjects with Device or System  

related complication (%) (N = 575)

 

Hemoptysis  

1 (0.2%) 

Sensor did not deploy  

1 (0.2%) 

Transient Ischemic Attack (TIA) 

1 (0.2%) 

Atypical chest pain  

1 (0.2%) 

Sepsis → death  

1 (0.2%) 

Atrial arrhythmia → death  

1 (0.2%) 

Arterial embolism (upper extremity)  

1 (0.2%) 

Pulmonary artery (in-situ) thrombus  

1 (0.2%) 

Total Subjects Experiencing a DSRC 

 

8 (1.4%

[1]

, 95.2% LCB 97.3%)

 

 
 
 

 

 

 

15

 

Содержание CardioMEMS CM1000

Страница 1: ...CardioMEMS HF System PA Sensor and Delivery System Model CM2000 User s Manual ...

Страница 2: ...plied sterile for single use only After use dispose of the Delivery System Do not resterilize Caution Federal U S law restricts this device to sale by or on the order of a physician Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and service marks of St Jude Medical...

Страница 3: ...re 11 Patient Identification Card 12 Patient Counseling Information 12 Clinical Study Information 13 Introduction 13 Purpose 14 Methods 13 Patient Demographics and Disposition 14 Primary and Secondary Endpoint Results 15 Primary Safety Endpoints 15 Primary Efficacy Endpoint 16 Secondary Endpoints 16 Medical Management 17 Results from the Entire Randomized Access Period 17 HF Hospitalizations 17 Mo...

Страница 4: ...ice clinic hospital or patient s home The data provided by the system includes PA pressure waveform Systolic Diastolic and Mean PA pressure Heart Rate This hemodynamic data is transmitted to a secure website that serves as the patient database so that PA monitoring information is available at all times through the internet Changes in PA pressure can be used in conjunction with heart failure signs ...

Страница 5: ...ve to diuretic therapy or who are on chronic renal dialysis Patients with congenital heart disease or mechanical right heart valve s Patients with known coagulation disorders Patients with a hypersensitivity or allergy to aspirin and or clopidogrel Patients who have undergone implantation of a Cardiac Resynchronization Device CRT within the past 3 months If the patient s BMI is greater than 35 mea...

Страница 6: ...e CardioMEMS HF System is affected by a change in body temperature 1mm Hg ΔºC Accuracy of the CardioMEMS HF System is slightly affected by large changes in elevation between the initial baseline calibration and subsequent measurements 2mm Hg 305 meters elevation change An accurate right heart catheterization is required to set system baseline mean pressure If a patient has a sensor implanted and a...

Страница 7: ... The effects of therapeutic ultrasound have not been determined If therapeutic ultrasound is required avoid contact with the sensor MRI Information Non clinical testing demonstrated that the sensor is MR Conditional A patient with this device can be scanned safely immediately after implantation under the following conditions o Static magnetic field of 1 5 or 3 0 Tesla o Maximum spatial gradient ma...

Страница 8: ...ion o Bronchitis o Pneumonia o Acute Bronchitis o Groin abscess o Methicilin resistant staphylococcal aureus infection o Pulmonary Infiltration o Sepsis Arrhythmias o Ventricular tachycardia o Atrial fibrillation o Ventricular arrhythmia o Ventricular fibrillation o Atrial fibrillation with rapid ventricular response o Atrial flutter o Cardiac dysrhythmias o Tachycardia o Wide complex tachycardia ...

Страница 9: ...e baseline Fluoroscope with digital angiography capabilities and ability to record and recall images C arm or fixed Blood pressure monitoring equipment for a right heart catheterization procedure Saline solution Radiopaque contrast media Package Inspection Inspect the package carefully before opening and check the Use By date on the product label Implant of the sensor is not recommended after its ...

Страница 10: ...gastrointestinal bleeding during the period in which dual antiplatelet therapy is given the physician should consider a proton pump inhibitor Patients at risk include the elderly or those with a history of gastroduodenal ulcers GERD esophagitis intestinal polyps or cancer Patients who smoke or who are using steroids or non steroidal anti inflammatory drugs may also be at risk Implantation Procedur...

Страница 11: ... vessel is within the lower lobe of either lung and the vessel is directed towards the feet and back Vessel diameter is 7 mm and has 30 degree angulation where body of Sensor will be placed Vessel diameter is 5 8 mm where the distal loop of Sensor will be placed See figure 3 Figure 3 Target implant site 8 Insert the sensor delivery guidewire through the PA catheter across the target implant site 9...

Страница 12: ...essure Baseline button on the Hospital Electronics System Enter the mean PA pressure value measured by the PA catheter 20 Set Cardiac Output Baseline Press the Set CO Baseline button on the Hospital Electronics System Enter the Cardiac Output value which was measured by the PA catheter Optional 21 Press the Take Reading button to capture baseline reading s 22 Remove antenna from under patient s ba...

Страница 13: ...F hospitalizations by managing patient PA pressures using the CardioMEMS HF System Methods Study Design 550 patients with NYHA Class III HF and a prior HF hospitalization within 12 months were randomized to standard of care plus the CardioMEMS HF System Treatment group 270 patients or to standard of care only Control group 280 patients All patients were implanted with the PA Sensor and took daily ...

Страница 14: ... similar with respect to baseline characteristics Table 5 Table 5 Patient Demographics Randomized Group Variables Treatment N 270 Control N 280 p value 1 Age years 61 3 12 98 270 61 8 12 73 280 0 5927 Male 194 270 71 9 205 280 73 2 0 7745 Race White 196 270 72 6 205 280 73 2 0 9236 Systolic BP mmHg 121 2 22 52 270 123 2 21 01 280 0 1286 Heart Rate bpm 72 4 12 91 269 73 0 12 14 280 0 4873 BMI 30 5 ...

Страница 15: ...n 567 98 6 were free from DSRC at 6 months lower confidence limit 97 3 p 0 0001 This lower limit of 97 3 is greater than the pre specified OPC of 80 Table 6a and 6b There were no sensor explants or repeat implants and all sensors were operational at 6 months for a freedom from sensor failure of 100 lower confidence limit 99 3 p 0 0001 This lower limit of 99 3 is greater than the pre specified OPC ...

Страница 16: ... 85 p 0 0002 Control Group n 280 120 0 44 1 p value and hazard ratio from negative binomial regression model Secondary Endpoints The four secondary efficacy endpoints were analyzed hierarchically at 6 months Table 9 At baseline both Treatment and Control patients had similar PA mean pressures When compared with patients in the Control group the patients in the Treatment group had greater reduction...

Страница 17: ...ndomized Access period was slightly larger than that seen during the 6 month primary endpoint period 33 vs 28 indicating durability of the treatment effect The number needed to treat NNT per year to prevent one HF hospitalization was 4 For every 100 patients treated 23 HF hospitalizations would be prevented per year Table 10 HF Hospitalization Rates During Randomized Access Number of HF Hospitaliz...

Страница 18: ... which cannot be separated from the treatment effect Treatment Effects in Women The CHAMPION study was not powered to show statistical significance for gender thus a complete determination of the effect of the device in women cannot be made At the request of FDA a post hoc gender analysis was conducted for the CHAMPION study and the initial finding of a treatment by gender interaction for the effe...

Страница 19: ...creating a competing risk for HF hospitalizations i e fewer control women were alive to have HF hospitalizations Figure 6 examines Freedom from HF Hospitalization or Death and indicates a non significant trend favoring women in the treatment group Figure 4 Freedom from HF Hospitalization over the Full Randomized Period Part 1 Figure 5 Freedom from Death over the Full Randomized Period Part 1 Figur...

Страница 20: ...on Endpoint of HFR hospitalization 0 573 0 191 0 0027 Part 1 Part 2 Cox Model Endpoint of first HFR hospitalization or Death 0 204 0 249 0 4121 Cox Model Endpoint of first HFR hospitalization 0 427 0 284 0 1331 AG Model with Frailty Endpoint of HFR hospitalization or Death 0 376 0 274 0 1697 AG Model with Frailty Endpoint of HFR hospitalization 0 588 0 271 0 0301 AG Model with RSE Endpoint of HFR ...

Страница 21: ...ders 2 0 7 2 33 3 1 0 4 1 9 1 3 0 5 3 17 6 0 0 0 0 Hemoptysis 1 1 1 1 2 2 0 0 Dyspnea 1 1 0 0 1 1 0 0 Cardiac disorders 1 0 4 1 16 7 1 0 4 1 9 1 2 0 4 2 11 8 0 0 0 0 Congestive heart failure 1 1 0 0 1 1 0 0 Ventricular tachycardia 0 0 1 1 1 1 0 0 Nervous system disorders 0 0 0 0 0 0 1 0 4 1 9 1 1 0 2 1 5 9 0 0 0 0 Dizziness 0 0 1 1 1 1 0 0 Vascular disorders 0 0 0 0 0 0 1 0 4 1 9 1 1 0 2 1 5 9 0 0...

Страница 22: ...s Over Part 1 and Part 2 Table 15 Serious Adverse Events Over Part 1 and Part 2 Part 1 Part 2 Treatment 270 Control 280 All Patients 550 All Patients 347 Subjects Events Subjects Events Subjects Events Subjects Events All Patients with an Event 198 73 3 797 217 77 5 956 415 75 5 1753 201 57 9 647 Cardiac disorders 138 51 1 333 151 53 9 443 289 52 5 776 119 34 3 238 Congestive heart failure 99 204 ...

Страница 23: ...tricular tachycardia 0 0 1 1 1 1 0 0 Sustained ventricular tachycardia 1 1 0 0 1 1 0 0 Tachycardia 0 0 1 1 1 1 0 0 Tricuspid insufficiency 0 0 1 1 1 1 0 0 Ventricular ectopic beats 1 1 0 0 1 1 0 0 Ventricular rhythm 0 0 1 1 1 1 0 0 Wide complex tachycardia 0 0 1 1 1 1 0 0 Wide complex ventricular tachycardia 1 1 0 0 1 1 0 0 Asystole 0 0 0 0 0 0 2 2 Congestive cardiomyopathy 0 0 0 0 0 0 1 1 End sta...

Страница 24: ...1 1 0 0 Serratia infection 0 0 1 1 1 1 0 0 Sinusitis 0 0 1 1 1 1 1 1 Staphylococcal infection 1 1 0 0 1 1 0 0 Urosepsis 1 1 0 0 1 1 0 0 Viral infection 1 1 0 0 1 1 1 1 Viremia 0 0 1 1 1 1 0 0 Wound infection 0 0 1 1 1 1 0 0 Arthritis infective 0 0 0 0 0 0 1 1 Bronchopneumonia 0 0 0 0 0 0 1 1 Clostridium difficile colitis 0 0 0 0 0 0 3 3 Cytomegalovirus viremia 0 0 0 0 0 0 1 1 Febrile cold excl flu...

Страница 25: ...atigue extreme 1 1 0 0 1 1 0 0 Febrile reaction 0 0 1 1 1 1 0 0 Fever of unknown origin 0 0 1 1 1 1 1 1 Infusion site bleeding 0 0 1 1 1 1 0 0 Multi organ failure 0 0 1 1 1 1 0 0 Non cardiac chest pain 0 0 1 1 1 1 1 1 Substernal chest pain 0 0 1 1 1 1 0 0 Sudden death 1 1 0 0 1 1 0 0 Swelling 1 1 0 0 1 1 0 0 Edema 0 0 0 0 0 0 1 1 Malaise 0 0 0 0 0 0 1 1 Organ failure 0 0 0 0 0 0 1 1 Thrombus in ca...

Страница 26: ...1 1 2 2 Unresponsive to stimuli 0 0 1 1 1 1 1 1 Vasovagal symptoms 0 0 1 1 1 1 0 0 Weakness left or right side 0 0 1 1 1 1 0 0 Brain injury 0 0 0 0 0 0 1 1 Restless leg syndrome 0 0 0 0 0 0 1 1 Todd s paralysis 0 0 0 0 0 0 1 1 Transient ischemic attacks 0 0 0 0 0 0 2 2 Vocal cord paralysis 0 0 0 0 0 0 1 1 Renal and urinary disorders 33 12 2 41 24 8 6 34 57 10 4 75 20 5 8 22 Acute on chronic renal ...

Страница 27: ...ischemia 0 0 0 0 0 0 1 1 Reflux esophagitis 0 0 0 0 0 0 1 1 Right upper quadrant pain 0 0 0 0 0 0 1 1 Small bowel obstruction 0 0 0 0 0 0 1 1 Metabolism and nutrition disorders 26 9 6 33 28 10 0 38 54 9 8 71 24 6 9 30 Dehydration 7 9 5 5 12 14 8 8 Hyperglycemia 3 4 5 6 8 10 1 1 Hypoglycemia 4 4 2 2 6 6 2 2 Failure to thrive 2 2 3 4 5 6 1 1 Hypokalemia 2 2 3 3 5 5 3 3 Hypovolemia 2 2 3 3 5 5 0 0 El...

Страница 28: ...ular assist device insertion 0 0 0 0 0 0 1 1 Injury poisoning and procedural complications 18 6 7 21 16 5 7 19 34 6 2 40 15 4 3 16 Lead dislodgement 2 2 2 2 4 4 0 0 Hip fracture 0 0 3 3 3 3 1 1 Bleeding postoperative 1 1 1 1 2 2 0 0 Device malfunction 0 0 2 2 2 2 0 0 Fall 2 2 0 0 2 2 2 2 Head injury 0 0 2 2 2 2 0 0 Lead conductor fracture 2 2 0 0 2 2 0 0 Subdural hematoma 2 2 0 0 2 2 2 2 Accidenta...

Страница 29: ...4 0 20 Anemia 11 12 8 10 19 22 11 12 Thrombocytopenia 1 1 1 1 2 2 1 1 Anemia microcytic 1 1 0 0 1 1 0 0 Leukocytosis 0 0 1 1 1 1 0 0 Neutropenia 0 0 1 1 1 1 0 0 Anemia aggravated 0 0 0 0 0 0 1 1 Hemolysis 0 0 0 0 0 0 1 5 Neutropenic fever 0 0 0 0 0 0 1 1 Investigations 10 3 7 10 5 1 8 6 15 2 7 16 3 0 9 4 Serum creatinine increased 2 2 1 2 3 4 0 0 Transplant evaluation 2 2 0 0 2 2 0 0 Anticoagulati...

Страница 30: ...yroidism 1 1 0 0 1 1 1 1 Myxedema 0 0 1 1 1 1 0 0 Immune system disorders 2 0 7 2 1 0 4 1 3 0 5 3 0 0 0 0 Amyloidosis 1 1 0 0 1 1 0 0 Heart transplant rejection 0 0 1 1 1 1 0 0 Transplant rejection 1 1 0 0 1 1 0 0 Skin and subcutaneous tissue disorders 0 0 0 0 3 1 1 3 3 0 5 3 3 0 9 4 Diabetic ulcer 0 0 1 1 1 1 0 0 Foot ulcer 0 0 1 1 1 1 0 0 Venous stasis ulcer 0 0 1 1 1 1 0 0 Decubitus ulcer 0 0 0...

Страница 31: ...nd an in situ thrombosis during the right heart catheterization procedure Both patients were treated and recovered without sequela There were no additional SADEs over Part 2 of the clinical trial FCC Statement This device is approved for wireless transmission under FCC ID number R3PCS A 000051 This device complies with Part 15 of the FCC Rules Operation is subject to the following conditions This ...

Страница 32: ...Manufacturer St Jude Medical 387 Technology Circle NW Atlanta Georgia 30313 USA 866 240 3335 sjm com July 2015 LA 400275 G ...

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