Pressure Variability Study

Heart Failure Clinical Trial

— APVS  

Official title:

Aquarius Pressure Variability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943941
• Other study ID #: Pressure
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 2017

Study information

• Verified date: April 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	The Lindner Research Center	Cincinnati	Ohio
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)