NCT00604903

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Aug 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2012

Enrollment Period

2.4 years

First QC Date

January 4, 2008

Last Update Submit

February 16, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

    6

Secondary Outcomes (1)

  • Device accuracy

    6 months

Study Arms (1)

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.

Device: Implant of Pressure sensor.

Interventions

Implant of Pressure sensor.DEVICE

Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.

Patients implanted with Pressure Sensor

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19196733RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Horst Sievert, M.D.

    CardioVascular Center Frankfurt, Seckbacher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 30, 2008

Study Start

August 23, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 17, 2017

Record last verified: 2012-02

Data Sharing

IPD Sharing
Will not share