Status:
COMPLETED
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
NA
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 predicti...
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 therap...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00400985
Start Date
January 1 2005
End Date
August 1 2009
Last Update
July 2 2025
Active Locations (2)
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1
UZA
Antwerp, Belgium
2
Royal Brompton
London, United Kingdom