N/A
N=501
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT00400985 ↗Enrolled (actual)
501
Serious AEs
8.4%
Results posted
Oct 2018
Primary outcome: Primary: Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion. — 58 hospitalization
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion. |
58 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00400985). 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.