Heart FailurePAPIRUSIINCT00604903
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
A study testing Implant of Pressure sensor. in people with Heart Failure, run by Boston Scientific Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implant of Pressure sensor.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 23 Aug 2006to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under the age of 18
- Pregnant women or women that plan to get pregnant during the study.
- Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
- Contraindication to antiplatelet therapy (aspirin and clopidogrel)
- Patients suffering from active infection (on antibiotic therapy)
- Known intracardiac mass (right atrial or right ventricular)
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- Patients who have been implanted with a VAD
- 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
- Patients that have lead implanted at the heart right side of the heart within the last 6 months
- Patients with any terminal illness, or with a life expectancy of less than 6 months
- Patients that are unable to lie flat for the duration of the procedure
- Patients that are unable to operate the home unit (due to physical or mental constrain)
- Patients after pneumonectomy
- Patients treated with oral anticoagulants INR > 1.5 prior to catheterization
- Patients with severe chronic renal failure (creatinine > 2.5 mg/dl)
- Patients suffered from acute myocardial infarction within the three months prior the study
- Patients that underwent open heart surgery within 4 weeks prior the study.
About this study
Official title: Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Implant of Pressure sensor.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of Pressure sensor.Device
Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with Pressure Sensor | Experimental | Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. Receives: Device: Implant of Pressure sensor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study start23 Aug 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, M.D., Principal investigator, CardioVascular Center Frankfurt, Seckbacher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604903
- Sponsor's protocol ID
- PAPIRUS II
- Acronym
- PAPIRUSII
- Status last verified
- Feb 2012
- First submitted
- 4 Jan 2008
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoppe UC, Vanderheyden M, Sievert H, Brandt MC, Tobar R, Wijns W, Rozenman Y. Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: multicentre experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II study. Heart. 2009 Jul;95(13):1091-7. doi: 10.1136/hrt.2008.153486. Epub 2009 Feb 5.
PubMed 19196733
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
- ClinicalTrials.gov ID
- NCT00604903
- Acronym / sponsor ID
- PAPIRUSII / PAPIRUS II
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2006 (actual)
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with Pressure Sensor | Experimental | Device: Implant of Pressure sensor.Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- Patients under the age of 18
- Pregnant women or women that plan to get pregnant during the study.
- Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
- Contraindication to antiplatelet therapy (aspirin and clopidogrel)
- Patients suffering from active infection (on antibiotic therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant of Pressure sensor.Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system. | Device | Patients implanted with Pressure Sensor |
Primary outcome
Serious adverse events related to implantation or the device
Time frame: 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
1 secondary outcome
Device accuracy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Results publication: PubMed 19196733Hoppe UC, Vanderheyden M, Sievert H, Brandt MC, Tobar R, Wijns W, Rozenman Y. Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: multicentre experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II study. Heart. 2009 Jul;95(13):1091-7. doi: 10.1136/hrt.2008.153486. Epub 2009 Feb 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Sievert, M.D. principal investigator
CardioVascular Center Frankfurt, Seckbacher
Questions about this trial
What is this clinical trial studying?
A study testing Implant of Pressure sensor. in people with Heart Failure, run by Boston Scientific Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events related to implantation or the device (time frame: 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00604903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.