Heart Failure, Congestive
Conditions
Keywords
Heart Failure, Congestive, Diagnostic, Ambulatory Monitoring, Intrathoracic Impedance
Brief summary
The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines for subject therapy management.
Detailed description
The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of Heart Failure related events associated with signs and symptoms of pulmonary congestion and in the subject HF therapy management. The OptiVol feature is based on the measurement of daily intrathoracic impedance values, measurements that can be used to track changes in the subject's thoracic fluid status over time. An Alert warns the patient whenever a programmable threshold has been reached. The study is divided into three phases. The first phase is double-blinded and designed to determine the sensitivity and positive predictive value of the OptiVol Fluid Trends data for the detection of Heart Failure related hospitalizations with signs and/or symptoms of pulmonary congestion. In the second phase of the study, the Alert is turned ON and the positive predictive value of the first OptiVol Patient Alert for the development of signs and/or symptoms of pulmonary congestion will be evaluated. The third phase of the study allows for remote subject therapy management using the OptiVol Patient Alert. The patient management strategy is then based on the experience gained in the second study phase Physician actions taken in the occurrence of a Patient Alert will be summarized.
Interventions
DEVICEImplantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.
SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully implanted InSync Sentry device (\< 34 days post implant or pocket revision)in the pectoral region; * At least one HF-related hospitalization that required administration of IV medication (inotropes, nitrates, diuretics) within the last 12 months * The Subject has a market released, transvenous, high voltage Right Ventricular lead * The Subject is able to detect a Patient Alert signal
Exclusion criteria
* \<18 years of age (or under a minimum age required by local law) * Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) * Post heart transplant or awaiting heart transplantation * Primary pulmonary hypertension * Renal insufficiency requiring dialysis Amendment to the inclusion criteria (Jul 06): * Inclusion of patients with Concerto/Virtuoso devices. * At least one HF-related hospitalization that required administration of IV (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion. | 34 days post device implant to 6 months |
Countries
Belgium, United Kingdom
Participant flow
Recruitment details
501 patients from 41 medical clinics in 13 countries were enrolled between March 4, 2005 and September 9, 2008.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 | 501 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 30 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | system modification | 8 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 10 |
| Cronic Heart Failure (CHF) patients with a Cardiac Resynchronization Therapy device system | 501 participants |
| Device therapy CRT-D | 393 units |
| Device therapy ICD | 108 units |
| Region of Enrollment Belgium | 44 participants |
| Region of Enrollment China | 6 participants |
| Region of Enrollment Czech Republic | 19 participants |
| Region of Enrollment Denmark | 21 participants |
| Region of Enrollment France | 58 participants |
| Region of Enrollment Germany | 70 participants |
| Region of Enrollment Greece | 38 participants |
| Region of Enrollment Israel | 29 participants |
| Region of Enrollment Italy | 115 participants |
| Region of Enrollment Poland | 18 participants |
| Region of Enrollment Slovakia | 22 participants |
| Region of Enrollment Spain | 23 participants |
| Region of Enrollment United Kingdom | 38 participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 422 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 52 / 501 |
| serious Total, serious adverse events | 42 / 501 |
Outcome results
Primary
Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.
Time frame: 34 days post device implant to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion. | 58 hospitalization |