DEFEAT-PE: Detect Fluid Early From Intra-thoracic Impedance Monitoring

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00916929
• Collaborator: (none)
• Enrollment: 162
• Locations: 34
• Arms: 2
• Duration (Months): 34
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Impedance Monitoring Feature	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Detect Fluid Early From Intra-thoracic Impedance Monitoring
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Implantable Cardioverter Defibrillator (ICD) Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).	Device: Impedance Monitoring Feature; Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
Other: Cardiac Resynchronization Therapy (CRT-D) Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.	Device: Impedance Monitoring Feature; Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads

Outcome Measures

Primary Outcome Measures

1. False Positive Rate [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.

Secondary Outcome Measures

1. Sensitivity [6-months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of kidney disease requiring hemodialysis

• Refractory end stage heart failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
2	Arizona Arrhythmia Research Center	Phoenix	Arizona	United States	85016
3	Arkansas Cardiology, PA	Little Rock	Arkansas	United States	72005
4	Little Rock Cardiology Clinic, PA	Little Rock	Arkansas	United States	72211
5	Glendale Memorial Hospital and MC	Glendale	California	United States	91204
6	Cardiac Rhythm Specialists, Inc	Northridge	California	United States	91325
7	Colorado Cardiac Alliance, LLC	Colorado Springs	Colorado	United States	80907
8	Shands Jacksonville	Jacksonville	Florida	United States	32209
9	Watson Clinic Center	Lakeland	Florida	United States	33805
10	Orlando Heart Center	Orlando	Florida	United States	32806
11	Tallahassee Research Institute	Tallahassee	Florida	United States	32308
12	Iowa Heart Center	West Des Moines	Iowa	United States	50266
13	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
14	Cardiology Consultants of East Michigan	Flint	Michigan	United States	48532
15	Thoracic Cardiovascular HC Found. (Sparrow Research)	Lansing	Michigan	United States	48910
16	Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39401
17	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
18	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
19	Associated Cardiovascular Consultants	Cherry Hill	New Jersey	United States	08034
20	New York Presbyterian Hospital / Cornell University	New York	New York	United States	10021
21	Mid Carolina Cardiology	Charlotte	North Carolina	United States	28204
22	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
23	Ohio State University	Columbus	Ohio	United States	43210
24	Mercy Hospital Fairfield	Fairfield	Ohio	United States	45014
25	Saint Vincent Consultants in Cardiovascular Diseases	Erie	Pennsylvania	United States	16502
26	Hospital of the University of PA	Philadelphia	Pennsylvania	United States	19104
27	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
28	York Hospital	York	Pennsylvania	United States	17403
29	Medical University of South Carolina	Charleston	South Carolina	United States	29425
30	Methodist University Hospital	Memphis	Tennessee	United States	38104
31	St Thomas Hospital	Nashville	Tennessee	United States	37205
32	South Texas Cardiovascular Consultants	San Antonio	Texas	United States	78201
33	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
34	The Hope Heart Institute	Bellevue	Washington	United States	98004

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: Edwin K Heist, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00916929
• Other Study ID Numbers: 40006062/D
• First Posted: Jun 10, 2009
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	Patient enrollment began on June 9, 2009 and ended on June 30, 2010. All patients had to be implanted at least 31 days prior to enrollment with a legally marketed St Jude Medical device capable of enabling the impedance monitoring feature.

Arm/Group Title	Implantable Cardioverter Defibrillator (ICD) Device	Cardiac Resynchronization Therapy (CRT-D) Device
Arm/Group Description	Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil	Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
Period Title: Overall Study
STARTED	80	82
COMPLETED	70	53
NOT COMPLETED	10	29

Baseline Characteristics

Arm/Group Title	ICD Device	CRT-D Device	Total
Arm/Group Description	Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil	Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.	Total of all reporting groups
Overall Participants	80	82	162
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	44 55%	36 43.9%	80 49.4%
>=65 years	36 45%	46 56.1%	82 50.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (14)	66 (13)	64 (13)
Sex: Female, Male (Count of Participants)
Female	32 40%	13 15.9%	45 27.8%
Male	48 60%	69 84.1%	117 72.2%
Region of Enrollment (participants) [Number]
United States	80 100%	82 100%	162 100%

Outcome Measures

1. Primary Outcome

Title	False Positive Rate
Description	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.
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cardiac Resynchronization Therapy (CRT-D) Device	Implantable Cardioverter Defibrillator (ICD) Device
Arm/Group Description	Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads	Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
Measure Participants	84	80
Number (95% Confidence Interval) [departures from device threshold]	1.8	1.49

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cardiac Resynchronization Therapy (CRT-D) Device, Implantable Cardioverter Defibrillator (ICD) Device
	Comments	For each patient cohort, the hypothesis is formally expressed as follows: H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate <1.5 per patient-year of follow-up The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	rate per patient year of follow up
	Estimated Value	1.5
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Sensitivity
Description	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).
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study were included in this analysis with a total of 82 patients in each group. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D during data collection period. These 2 patients were censored from ICD cohort and included in CRT-D cohort at the time of upgrade based on as-treated analysis principle.

Arm/Group Title	Cardiac Resynchronizaiton Therapy (CRT-D) Device	Implantable Cardioverter Defibrillator (ICD) Device
Arm/Group Description	Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads	Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
Measure Participants	84	80
Number (95% Confidence Interval) [percentage of true positives]	40	30.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cardiac Resynchronization Therapy (CRT-D) Device, Implantable Cardioverter Defibrillator (ICD) Device
	Comments	For each patient cohort, the hypothesis is formally expressed as follows: H0: Sensitivity ≤ 50% Ha: Sensitivity > 50% The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	sensitivity
	Estimated Value	50
	Confidence Interval	(1-Sided) 95%; 50 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5
	Estimation Comments

Adverse Events

Time Frame	755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
Arm/Group Title	CRT-D Device		ICD Device
Arm/Group Description	Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil		Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
All Cause Mortality
	CRT-D Device		ICD Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CRT-D Device		ICD Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/82 (2.4%)		3/80 (3.8%)
Cardiac disorders
Device Migration	1/82 (1.2%)	1	0/80 (0%)	0
Loss of Capture (LV lead related)	1/82 (1.2%)	1	0/80 (0%)	0
Lead dislodgement / migration (RV lead related)	0/82 (0%)	0	1/80 (1.3%)	1
Infection (system related)	0/82 (0%)	0	2/80 (2.5%)	2
Other (Not Including Serious) Adverse Events
	CRT-D Device		ICD Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/82 (7.3%)		8/80 (10%)
Cardiac disorders
Elevated Pacing Threshold (LV lead related)	1/82 (1.2%)	1	0/80 (0%)	0
Phrenic Nerve / Diaphragmatic Stimulation (LV lead related)	1/82 (1.2%)	1	0/80 (0%)	0
Twiddler Syndrome	1/82 (1.2%)	1	0/80 (0%)	0
Therapy for Non Ventricular Rhythm	3/82 (3.7%)	3	6/80 (7.5%)	8
Bleeding / Hematoma	0/82 (0%)	0	1/80 (1.3%)	1
Unable to Turn Impedance Data Collection on	0/82 (0%)	0	1/80 (1.3%)	1

Limitations/Caveats

There were no limitations of the trial.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.