Back to resultsPressure Variability Study (APVS)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Subject has a history of primary PAH
Sites / Locations
- University of California, San Francisco
- The Lindner Research Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All participants
Arm Description
All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP)
Outcomes
Primary Outcome Measures
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
Posture defined as lying left side down compared to baseline supine
Secondary Outcome Measures
Change in PAP During Change in Respiration
Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.
Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
Full Information
NCT ID
NCT02943941
First Posted
August 8, 2016
Last Updated
April 10, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT02943941
Brief Title
Pressure Variability Study
Acronym
APVS
Official Title
Aquarius Pressure Variability Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a prospective, multi-center, observational study with enrollment up to 30 subjects at 2 U.S. sites. All study data can be collected on a single day as a one-time visit (lasting approximately 90-120 minutes).
This study is a Non-Significant Risk (NSR) Investigational Device Exemption (IDE) study as LINQ™ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM.
The patient will come to the clinic for a single in-office visit. PA pressure will be measured while the patient is in a variety of positions and during different respiratory exercises and after brief exertion. Data will be collected on eCRFs.
The effects of the different postures, respiration and exertion will be quantified using descriptive statistics (mean, standard deviation).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Other
Arm Description
All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP)
Intervention Type
Other
Intervention Name(s)
Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.
Other Intervention Name(s)
Interventions included: Changing posture, changing respiration, and changing exertion
Intervention Description
Cardiac Monitor with LINQ™ HF Investigational RAMware download
Primary Outcome Measure Information:
Title
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
Description
Posture defined as lying left side down compared to baseline supine
Time Frame
Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Secondary Outcome Measure Information:
Title
Change in PAP During Change in Respiration
Description
Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.
Time Frame
Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)
Title
Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
Time Frame
Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Subject has a history of primary PAH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verla Laager
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Pressure Variability Study
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