Pressure Variability Study (APVS)

Medtronic

Status: Completed

Conditions: Heart Failure

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02943941

Pressure

Details and patient eligibility

About

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

Full 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).

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

All participants

Other group

Description:

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

Treatment:

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