Heart Failure
Conditions
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).
Interventions
OTHERReveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.
Cardiac Monitor with LINQ™ HF Investigational RAMware download
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Single arm | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 68.8 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
Posture defined as lying left side down compared to baseline supine
Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Population: Only 14 patients able to provide data to contribute to analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Design | Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture | 27.7 mmHg | Standard Deviation 10.3 |
p-value: 0.429ANOVA
Secondary
Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
Time frame: Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Design | Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest. | 27.7 mmHg | Standard Deviation 12.2 |
p-value: <0.001ANOVA
Secondary
Change in PAP During Change in Respiration
Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.
Time frame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Design | Change in PAP During Change in Respiration | 25.9 mmHg | Standard Deviation 13.3 |
p-value: 0.059ANOVA