Trial Outcomes & Findings for Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements (NCT NCT03608826)
NCT ID: NCT03608826
Last Updated: 2022-12-23
Results Overview
The primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
COMPLETED
NA
12 participants
18 months
2022-12-23
Participant Flow
Participant milestones
| Measure |
Single Arm Study
Observational data collection study
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Single Arm Study
Observational data collection study
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Heart Transplant
|
3
|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
Baseline characteristics by cohort
| Measure |
Single Arm Study
n=12 Participants
Single Arm Observational study.
|
|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
History of Coronary Artery Disease
|
9 Participants
n=5 Participants
|
|
History of Hypertension
|
9 Participants
n=5 Participants
|
|
History of Atrial Fibrillation
|
5 Participants
n=5 Participants
|
|
Left Ventricular Ejection Fraction
|
36.0 %
STANDARD_DEVIATION 21.2 • n=5 Participants
|
|
NYHA class
Class-II
|
2 Participants
n=5 Participants
|
|
NYHA class
Class-III
|
9 Participants
n=5 Participants
|
|
NYHA class
Missing
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsThe primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
Outcome measures
| Measure |
Observation
n=11 Participants
Observation arm
|
|---|---|
|
Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Pulmonary Artery Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure.
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 monthsThe primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
Outcome measures
| Measure |
Observation
n=11 Participants
Observation arm
|
|---|---|
|
Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Right Atrial Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure.
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 monthsThe primary objective was to characterize the relationship between changes in Reveal LINQ™ subcutaneous impedance and right heart hemodynamic measurements, resulting from: 1) short-term drug and/or exercise challenges during right heart catheterization procedures or 2) long-term daily trends of physiologic data, in patients with heart failure.
Outcome measures
| Measure |
Observation
n=9 Participants
Observation arm
|
|---|---|
|
Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events.
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 monthsA heart failure event is defined as any cardiovascular-related (including hypervolemia) Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: * Admission with secondary/tertiary diagnosis of HF * Emergency Department * Ambulance * Observation Unit * Urgent Care
Outcome measures
| Measure |
Observation
n=9 Participants
Observation arm
|
|---|---|
|
Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events.
|
0 Participants
|
Adverse Events
Single Arm
Serious adverse events
| Measure |
Single Arm
n=12 participants at risk
Observation Arm
|
|---|---|
|
Cardiac disorders
Hospitalization
|
8.3%
1/12 • Adverse event data was collected up to 18 months from enrollment.
|
|
Cardiac disorders
Death
|
25.0%
3/12 • Adverse event data was collected up to 18 months from enrollment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place