Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

Heart Failure, Congestive Clinical Trial

— SENSE-HF  

Official title:

Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400985
• Other study ID #: SENSE-HF, V.1, Dec.8, 2004
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: August 2009

Study information

• Verified date: January 2018
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• Implantable 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.

Locations

Country	Name	City	State
Belgium	UZA	Antwerpen
United Kingdom	Royal Brompton	London

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

References & Publications (2)

Conraads VM, Tavazzi L, Santini M, Oliva F, Gerritse B, Yu CM, Cowie MR. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Eur Heart J. 2011 Se — View Citation

Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005 Aug 9;112(6):841-8. Epub 2005 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.		34 days post device implant to 6 months

External Links

•   Public website