Pressure Variability Study (APVS)

Aquarius Pressure Variability Study

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.

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).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All participants; 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.; Cardiac Monitor with LINQ™ HF Investigational RAMware download; Other Names: Interventions included: Changing posture, changing respiration, and changing exertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PAP During Change in Respiration	Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.	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)

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Director: Verla Laager, Medtronic

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: October 23, 2016
• First Posted (Estimate): October 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PRESSURE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED