Pressure Variability Study

Not Applicable

Completed

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

• Registration Number: NCT02943941
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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).

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-10-23
• Study First Posted: 2016-10-25
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2017-05-22
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-10
• Results First Posted: 2019-04-12
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.	All participants enrolled in a single arm to evaluate effect of variables (posture, respiration, exertion) on pulmonary artery pressure (PAP)

Primary Outcome Measures

Name	Time	Method
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture	Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)	Posture defined as lying left side down compared to baseline supine

Secondary Outcome Measures

Name	Time	Method
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)
Change in PAP During Change in Respiration	Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)	Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.

Trial Locations

Locations (2)

The Lindner Research Center; 🇺🇸 Cincinnati, Ohio, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States