NCT02943941

Brief Summary

The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

2 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

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 12, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

August 8, 2016

Results QC Date

May 22, 2017

Last Update Submit

April 10, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture

    Posture defined as lying left side down compared to baseline supine

    Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)

Secondary Outcomes (2)

  • Change in PAP During Change in Respiration

    Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)

  • Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.

    Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)

Study Arms (1)

All participants

OTHER

All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP)

Other: Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.

Interventions

Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.OTHER

Cardiac Monitor with LINQ™ HF Investigational RAMware download

Also known as: Interventions included: Changing posture, changing respiration, and changing exertion
All participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Investigator believes the patient's condition is sufficiently stable to safely participate in the study procedures
  • Subject is currently implanted with a commercially available pulmonary artery pressure sensor and device communication has been reliable (recent history of successful communications with patient communication system)

You may not qualify if:

  • Subject has a history of primary PAH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Verla Laager
Organization
Medtronic Inc
verla.l.laager@medtronic.com
(800) 328.2518

Study Officials

  • Verla Laager

    Medtronic

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

October 25, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 12, 2019

Results First Posted

April 12, 2019

Record last verified: 2019-04

Locations

US(2)