NCT02943941

Pressure Variability Study

Aquarius Pressure Variability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-10-25
• Last updated: 2019-04-12
• Results posted: 2019-04-12

Locations

2 sites across 1 country: United States