NCT00420108

Brief Summary

The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical practice methods to determine if heart failure patients are ready for hospital discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2006

Typical duration for all trials

Geographic Reach
1 country

5 active sites

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

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 20, 2010

Status Verified

August 1, 2010

Enrollment Period

3.2 years

First QC Date

January 8, 2007

Last Update Submit

August 18, 2010

Conditions

Heart Failure, CongestiveCardiac Pacemaker, Artificial

Keywords

Heart Failure, CongestiveCardiac Pacemaker, ArtificialVentricular Pressure

Eligibility Criteria

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

The study population is hospitalized patients who have an implanted Medtronic device with Optivol capability.

You may qualify if:

  • Patients implanted with a Medtronic InSync Sentry or subsequent FDA-approved Medtronic device with the OptiVol capability for \>30 days.
  • Anticipated hospitalization stay \>48 hours
  • Hospitalized patients experiencing worsening heart failure with symptoms of lung/pulmonary congestion.

You may not qualify if:

  • Anemia - admission hemoglobin \<8.0 g/dL
  • Patients residing in convalescence center prior to admission or known to be discharged to a convalescence center or hospice, where discharge could be based on bed availability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Heartland Health

Saint Joseph, Missouri, 64506, United States

Location

Cardiovascular Associates of Delaware Valley

Elmer, New Jersey, 083618, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Main Line Health Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens to be retained

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • David J Whellan, MD MHS

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

December 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 20, 2010

Record last verified: 2010-08

Locations

US(5)