Heart Failure
Conditions
Brief summary
The purpose of this study is to evaluate and document appropriate clinical safety and performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated application software. It is a small clinical trial to determine the feasibility of the device. The primary outcome measure relates to feasibility and not to health outcomes.
Detailed description
This study was a prospective feasibility, non-randomised, singlearm, multi-centre, interventional clinical investigation performed at 4 international sites. Patients were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. Measurements were taken with the Remon CHF Home Unit and the Remon CHF Clinic System. Follow-up visits took place at one, three and six months after implant. Per protocol, a minimum of 30 patients was required to demonstrate safety of the device. The study was conducted in accordance with ISO 14155:2003 (parts I and II), the Declaration of Helsinki and all applicable local and national regulations in the countries of submission.
Interventions
DEVICEImplant of Pressure sensor.
Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Masking description
No masking
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients who exhibit signs and symptoms of NYHA Class III or IV heart failure. * Patients who are able to visit the clinic frequently during the 6 months following implantation. * Patients who are willing and able to perform all follow-up procedures.
Exclusion criteria
1. Patients under the age of 18 2. Pregnant women or women that plan to get pregnant during the study. 3. Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves 4. Contraindication to antiplatelet therapy (aspirin and clopidogrel) 5. Patients suffering from active infection (on antibiotic therapy) 6. Known intracardiac mass (right atrial or right ventricular) 7. Patients who have been implanted with a VAD 8. Patients who are candidates for listing for heart transplantation if it is deemed that they have a possibility of receiving a heart within the next 6 months 9. Patients that have lead implanted at the heart right side of the heart within the last 6 months 10. Patients with any terminal illness, or with a life expectancy of less than 6 months 11. Patients that are unable to lie flat for the duration of the procedure 12. Patients that are unable to operate the home unit (due to physical or mental constrain) 13. Patients after pneumonectomy 14. Patients treated with oral anticoagulants INR \> 1.5 prior to catheterization 15. Patients with severe chronic renal failure (creatinine \> 2.5 mg/dl) 16. Patients suffered from acute myocardial infarction within the three months prior the study 17. Patients that underwent open heart surgery within 4 weeks prior the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events related to implantation or the device | 6 | Primary Device Safety Objective: Serious Adverse Device Effects rate during 6 months following implantation (device or delivery system related) and Implantation related Serious Adverse Events rate during 6 months following implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device accuracy | 6 months | Compare accuracy of Remon Pressure Sensor with Millar catheter (invasive way of measuring pulmonary artery pressure). Secondary end points included accuracy of the measured PA pressure, functionality of the system and evaluation of pressure readings at different postures. |
Outcome results
None listed