NCT00400985

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

October 22, 2018

Completed
Last Updated

July 2, 2025

Status Verified

January 1, 2018

Enrollment Period

4.6 years

First QC Date

September 13, 2005

Results QC Date

February 14, 2017

Last Update Submit

June 30, 2025

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, CongestiveDiagnosticAmbulatory MonitoringIntrathoracic Impedance

Outcome Measures

Primary Outcomes (1)

  • Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.

    34 days post device implant to 6 months

Study Arms (1)

Implantable Device diagnostics

OTHER

All enrolled subjects were implanted with a device. Audible Device diagnostics turned on or off

Device: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.

Interventions

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.

Implantable Device diagnostics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZA

Antwerp, Belgium

Location

Royal Brompton

London, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 16061743BACKGROUND

  • 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 Sep;32(18):2266-73. doi: 10.1093/eurheartj/ehr050. Epub 2011 Feb 28.

    PMID: 21362703RESULT

  • Conraads 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.

    PMID: 24519908DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureDisease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director CRDM
Organization
Medtronic BRC, The Netherlands, Maastricht
+31 43 3566

Study Officials

  • Viviane Conraads, Professor

    UZA, Antwerpen, Belgium

    PRINCIPAL INVESTIGATOR

  • Martin Cowie, Professor

    Royal Brompton Hospital, London, UK

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

November 17, 2006

Study Start

January 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 2, 2025

Results First Posted

October 22, 2018

Record last verified: 2018-01

Locations

BE(1)GB(1)