Pressure Variability Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/8/2017 |
| Start Date: | July 2016 |
| End Date: | November 2016 |
| Contact: | Verla Laager |
| Email: | verla.l.laager@medtronic.com |
| Phone: | 763-526-2875 |
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.
under different conditions of posture, respiration and exertion.
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).
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).
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
We found this trial at
2
sites
1600 Holloway Avenue
San Fransisco, California 94143
San Fransisco, California 94143
Principal Investigator: Van Selby, MD
Phone: 415-476-9128
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Cincinnati, Ohio 45219
Principal Investigator: Eugene Chung, MD
Phone: 513-585-1777
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