Heart Failure, CongestiveSENSE-HFNCT00400985
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
A study testing Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool. in people with Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2005to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- <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):
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Congestive
- Being tested
- Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.
- Keywords
- Heart Failure, Congestive, Diagnostic, Ambulatory Monitoring, Intrathoracic Impedance
- Medical subject headings
- Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.Device
SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.
| Study group | Role | What they receive |
|---|---|---|
| Implantable Device diagnostics | Other | All enrolled subjects were implanted with a device. Audible Device diagnostics turned on or off Receives: Device: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.
Measured: 34 days post device implant to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJan 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Viviane Conraads, Professor, Principal investigator, UZA, Antwerpen, BelgiumMartin Cowie, Professor, Principal investigator, Royal Brompton Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400985
- Sponsor's protocol ID
- SENSE-HF, V.1, Dec.8, 2004
- Acronym
- SENSE-HF
- Status last verified
- Jan 2018
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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. doi: 10.1161/CIRCULATIONAHA.104.492207. Epub 2005 Aug 1.
PubMed 16061743Conraads 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 Sep;32(18):2266-73. doi: 10.1093/eurheartj/ehr050. Epub 2011 Feb 28.
PubMed 21362703Conraads VM, Spruit MA, Braunschweig F, Cowie MR, Tavazzi L, Borggrefe M, Hill MR, Jacobs S, Gerritse B, van Veldhuisen DJ. Physical activity measured with implanted devices predicts patient outcome in chronic heart failure. Circ Heart Fail. 2014 Mar 1;7(2):279-87. doi: 10.1161/CIRCHEARTFAILURE.113.000883. Epub 2014 Feb 11.
PubMed 24519908
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
- ClinicalTrials.gov ID
- NCT00400985
- Acronym / sponsor ID
- SENSE-HF / SENSE-HF, V.1, Dec.8, 2004
- Conditions
- Heart Failure, Congestive
- Keywords
- Heart Failure, Congestive, Diagnostic, Ambulatory Monitoring, Intrathoracic Impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Jan 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Posted 22 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable Device diagnostics | Other | Device: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.All enrolled subjects were implanted with a device. Audible Device diagnostics turned on or off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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 exclusion criteria (6 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Implantable Device diagnostics |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16061743Yu 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. doi: 10.1161/CIRCULATIONAHA.104.492207. Epub 2005 Aug 1.
- Results publication: PubMed 21362703Conraads 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 Sep;32(18):2266-73. doi: 10.1093/eurheartj/ehr050. Epub 2011 Feb 28.
- Derived from this study: PubMed 24519908Conraads VM, Spruit MA, Braunschweig F, Cowie MR, Tavazzi L, Borggrefe M, Hill MR, Jacobs S, Gerritse B, van Veldhuisen DJ. Physical activity measured with implanted devices predicts patient outcome in chronic heart failure. Circ Heart Fail. 2014 Mar 1;7(2):279-87. doi: 10.1161/CIRCHEARTFAILURE.113.000883. Epub 2014 Feb 11.
- Public websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viviane Conraads, Professor principal investigator
UZA, Antwerpen, Belgium
Martin Cowie, Professor principal investigator
Royal Brompton Hospital, London, UK
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool. in people with Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00400985, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.