N/A
N=16
Pressure Variability Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02943941 ↗Enrolled (actual)
16
Serious AEs
—
Results posted
Apr 2019
Primary outcome: Primary: Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture — 27.7 mmHg — p=0.429
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body. (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture |
27.7 | 0.429 |
| SECONDARY Change in PAP During Change in Respiration |
25.9 | 0.059 |
| SECONDARY Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest. |
27.7 | <0.001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02943941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.