An interventional study of Implant of Pressure sensor. in Heart Failure, sponsored by Boston Scientific Corporation. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-02-17.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Device feasibility
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 42 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
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Exclusion Criteria:
Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system.
Device: Implant of Pressure sensor.
Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
Serious adverse events related to implantation or the device
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
Time frame: 6
Device accuracy
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.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Boston Scientific Corporation