Heart FailureDEFEAT-PENCT00916929

Detect Fluid Early From Intra-thoracic Impedance Monitoring

A study testing Impedance Monitoring Feature in people with Heart Failure, run by Abbott Medical Devices at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Impedance Monitoring Feature
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 34 sitesUnited States
Study dates: May 2009to Mar 2012
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

Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months

Who cannot join

History of kidney disease requiring hemodialysis
Refractory end stage heart failure

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

The Hope Heart Institute
Bellevue, Washington, 98004
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Medical University of South Carolina
Charleston, South Carolina, 29425
Mid Carolina Cardiology
Charlotte, North Carolina, 28204
Associated Cardiovascular Consultants
Cherry Hill, New Jersey, 08034
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Colorado Cardiac Alliance, LLC
Colorado Springs, Colorado, 80907
Ohio State University
Columbus, Ohio, 43210
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, 16502
Mercy Hospital Fairfield
Fairfield, Ohio, 45014
Cardiology Consultants of East Michigan
Flint, Michigan, 48532
Glendale Memorial Hospital and MC
Glendale, California, 91204
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Shands Jacksonville
Jacksonville, Florida, 32209
Watson Clinic Center
Lakeland, Florida, 33805
Thoracic Cardiovascular HC Found. (Sparrow Research)
Lansing, Michigan, 48910
Arkansas Cardiology, PA
Little Rock, Arkansas, 72005
Little Rock Cardiology Clinic, PA
Little Rock, Arkansas, 72211
Methodist University Hospital
Memphis, Tennessee, 38104
St Thomas Hospital
Nashville, Tennessee, 37205
New York Presbyterian Hospital / Cornell University
New York, New York, 10021
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Cardiac Rhythm Specialists, Inc
Northridge, California, 91325
Orlando Heart Center
Orlando, Florida, 32806
Hospital of the University of PA
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85016
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
Tallahassee Research Institute
Tallahassee, Florida, 32308
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Iowa Heart Center
West Des Moines, Iowa, 50266
York Hospital
York, Pennsylvania, 17403

Other trials in United States

About this study

To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.

Conditions: Heart Failure
Being tested: Impedance Monitoring Feature
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Impedance Monitoring FeatureDevice
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads

Study groups in NCT00916929
Study group	Role	What they receive
Implantable Cardioverter Defibrillator (ICD)	Other	Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD). Receives: Device: Impedance Monitoring Feature
Cardiac Resynchronization Therapy (CRT-D)	Other	Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device. Receives: Device: Impedance Monitoring Feature

What is being measured

The primary outcome is the main question the study is designed to answer.

False Positive Rate
False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.
Measured: 6-months

Secondary outcomes (1)

Sensitivity
Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).
Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Mar 2012

First posted10 Jun 2009 (estimated)
Study startMay 2009
Primary completionFeb 2011
Study completionMar 2012

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.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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: Non-randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00916929
Sponsor's protocol ID: 40006062/D
Acronym: DEFEAT-PE
Status last verified: Feb 2019
First submitted: 8 Jun 2009
Last updated: 19 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Detect Fluid Early From Intra-thoracic Impedance Monitoring
ClinicalTrials.gov ID: NCT00916929
Acronym / sponsor ID: DEFEAT-PE / 40006062/D
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Feb 2011 (actual)
Study completion: Mar 2012 (actual)
First posted: 10 Jun 2009 (estimated)
Results: Posted 24 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Implantable Cardioverter Defibrillator (ICD)	Other	Device: Impedance Monitoring FeatureImpedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).
Cardiac Resynchronization Therapy (CRT-D)	Other	Device: Impedance Monitoring FeatureImpedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months

Key exclusion criteria (2 listed)

History of kidney disease requiring hemodialysis
Refractory end stage heart failure

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
Impedance Monitoring FeatureAlgorithm in cardiac device that measures intra-thoracic impedance from the implanted leads	Device	Cardiac Resynchronization Therapy (CRT-D), Implantable Cardioverter Defibrillator (ICD)

Primary outcome

False Positive Rate
Time frame: 6-months
False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.

1 secondary outcome

Sensitivity
Time frame: 6-months

Results and safety

Results posted to the registry on 24 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implantable Cardioverter Defibrillator (ICD) Device	80	70
Cardiac Resynchronization Therapy (CRT-D) Device	82	53

Primary outcome: False Positive Rate

Time frame: 6-months. Number (95% Confidence Interval). Unit: departures from device threshold

Measure	Cardiac Resynchronization Therapy (CRT-D) Device n = 84	Implantable Cardioverter Defibrillator (ICD) Device n = 80
Value	1.8 (1.8 to 2.17)	1.49 (1.49 to 1.8)

Cardiac Resynchronization Therapy (CRT-D) Device vs Implantable Cardioverter Defibrillator (ICD) Device: rate per patient year of follow up: 1.5, exact method

Population analysed: All patients participating in the study were included in the analysis with a total of 82 patients in each arm. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D. These 2 patients were censored from the ICD cohort and included in the CRT-D cohort at the time of upgrade based on as-treated analysis principle resulting.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRT-D Device	2 of 82 (2.4%)	6 of 82 (7.3%)	Not reported
ICD Device	3 of 80 (3.8%)	8 of 80 (10%)	Not reported

Limitations and caveats (from the sponsor): There were no limitations of the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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.

Edwin K Heist, MD, PhD study chair

Massachusetts General Hospital

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Impedance Monitoring Feature in people with Heart Failure, run by Abbott Medical Devices at 34 sites in United States.

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 2 inclusion and 2 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. 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 24 Jun 2013). 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?

False Positive Rate (time frame: 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 NCT00916929.

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 19 Feb 2019.