NCT02337790

Brief Summary

This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 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

January 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

January 9, 2015

Last Update Submit

December 28, 2015

Conditions

Heart FailureHypertension

Keywords

HypertensionHeart FailureFluids

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Interference between implanted devices and CoVa Monitoring System

    One time for up to 15 minutes during a clinic visit for device interrogation

Study Arms (1)

Cohort 1

Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be from the Imperial Cardiac Clinic

You may qualify if:

  • Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
  • Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
  • Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
  • Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

You may not qualify if:

  • Subject is participating in another clinical study that may affect the results of either study.
  • Subject is unable or not willing to wear electrode patches as required.
  • Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
  • Subject is considered by the PI to be medically unsuitable for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial Cardiac Center

Imperial, California, 92251, United States

Location

MeSH Terms

Conditions

Heart FailureHypertension

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Matthew J Banet, PhD

    Baxter Healthcare Corporation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

US(1)