NCT00893828

Brief Summary

The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II. Pressure readings from the investigational device will continue to be collected and will be correlated to physiological changes during activities of daily living and protocol defined tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

May 5, 2009

Last Update Submit

February 16, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device.

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients previously implanted with a RemonCHF device

You may qualify if:

  • Patient has been enrolled in the PAPIRUS II Study and has a RemonCHF pressure sensor implanted
  • Patient is willing and able to provide informed consent, participate in the Safety Follow-up Program and/or in the required tests associated with the clinical investigation (Core Study Program) at an approved clinical investigational center and at the intervals defined by the Clinical Investigational Plan.

You may not qualify if:

  • Patient enrolled in PAPIRUS II but not implanted with a RemonCHF Pressure Sensor
  • Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study (with the exception of the PAPIRUS II Study). Each instance would be brought to the sponsor to determine eligibility.
  • Age \< 18 years
  • Women of childbearing potential who are, or might be, pregnant at the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, Germany

Location

Biospecimen

Retention: NONE RETAINED

Whole Blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Uta C Hoppe, Prof. Dr.

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2011

Study Completion

January 1, 2017

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

DE(1)