Evaluation of Cardiac Compass With OptiVol in the Early D... | NCT00510198

Status Module

Description Module

Label	Type	Description	Intervention Names
Control Arm 1: SOC and CC with OptiVol	Active Comparator	Standard of Care and Cardiac Compass with OptiVol as the Control. Intervention is standard of care, such as symptom assessment with the addition of viewing Cardiac Compass trends and the OptiVol diagnostic.	Device: Cardiac Compass with OptiVol Fluid Status Monitoring
Control Arm 2: SOC	Active Comparator	Intervention is Standard of Care alone, such as assessment of symptoms, only. Device trending information, but OptiVol is not allowed.	Device: Standard of Care alone (clinical assessment)

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Compass with OptiVol Fluid Status Monitoring	Device	Review of Cardiac Compass with OptiVol Fluid Status Monitoring	Control Arm 1: SOC and CC with OptiVol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Heart-Failure Hospitalization or All-Cause Death	A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring ("Access Arm") compared to HF subjects managed with standard clinical assessment alone ("Control Arm")	Up to five years
Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm	A safety composite event is defined as an event that includes one or more of the following: Syncope, Worsening renal function resulting in IV therapy, ultrafiltration, or dialysis, Hypotension and/or hypovolemia resulting in the administration of IV fluids, Clinically significant electrolyte abnormalities resulting in IV replacement or ER/hospitalization for correction, Appropriately detected sustained VT/VF episode, Death	Up to five years

Secondary Outcomes

Measure	Description	Time Frame
Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations	To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm	up to five years
Cardiovascular Hospitalizations

Eligibility Module

Eligibility Criteria

Inclusion Criteria

The following criteria apply to all subjects:

Subject has a CRT-D or dual chamber ICD with Cardiac Compass and OptiVol Fluid Status Monitoring implanted in the pectoral region at least 30 days prior to enrollment. CRT-D/ICD must be supported by the Medtronic CareLink Network.
Subject has a market-released, transvenous, high voltage RV lead
Subject has a market-released RA lead
If subject has an LV lead, it must be compatible, not Y-adapted and not currently under investigation
Subject's heart failure regimen (i.e. beta blocker and ACE inhibitor (or substitute) unless documented evidence of intolerance is available) adheres to current ACC/AHA guidelines for management of chronic heart failure in adult patients
Subject has a history of at least one heart failure related hospitalization, Emergency Department (ED) visit, or urgent visit necessitating IV diuretic, IV inotropic, IV vasodilator, or other parenteral therapy within 12 months prior to baseline evaluation
Subject is at least 18 years of age
Subject is willing and able to comply with the Clinical Investigation Plan (e.g. willing and able to remain available for follow-up visits, use SentryCheck, etc.)
Subject is willing and able to transmit data using the Medtronic CareLink Network
Subject (or subject's legally authorized representative) is willing and able to sign and date the study Informed Consent and HIPAA Authorization (U.S.)

Exclusion Criteria

The following criteria apply to all subjects:

Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
Subject received a coronary artery bypass graft or valve surgery in the last 90 days
Subject had a myocardial infarction (MI) in the last 90 days.
Subject is indicated for valve replacement/repair
Subject's life expectancy due to non-cardiac reasons is less than six months
Subject has serum creatinine > 2.5 mg/dL measured within 30 days prior to enrollment.
Subject is on chronic renal dialysis
Subject is on continuous or intermittent (> 2 stable infusions per week) infusion therapy for HF
Subject has complex and uncorrected congenital heart disease
Subject is enrolled in a Disease Management Program where an outside vendor, company or service is employed to determine, monitor, and/ or alert a clinician or subject to weight changes or other HF signs or symptoms via interactive or passive systems
Subject is implanted with a cardiac hemodynamic monitor or left ventricular assist device(LVAD)
Subject is enrolled in a concurrent study, with the exception of a study approved by the Medtronic PRECEDE-HF Clinical Trial Leader prior to enrollment

Name	Affiliation	Role
PRECEDE-HF Study Team	Medtronic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
		Anchorage	Alaska	99508	United States

Results Section

Participant Flow Module

ID	Title	Description
FG000	Access Arm	Standard of Care and Cardiac Compass with OptiVol
FG001	Control Arm	Standard of Care alone

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Heart-Failure Hospitalization or All-Cause Death

A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring ("Access Arm") compared to HF subjects managed with standard clinical assessment alone ("Control Arm")

all randomized subjects; intention to treat

Posted

Number

Participants with an Event

Up to five years

ID	Title	Description
OG000	Access Arm	Standard of Care and Cardiac Compass with OptiVol
OG001	Control Arm	Standard of Care alone

Units	Counts
Participants	OG00059 OG00158

Title

Denominators

Categories

Title	Measurements
	OG00014 OG0019

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.	Log Rank		0.23	The log-rank test was conducted at an alpha level of 0.05. The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.					2-Sided	95							Superiority or Other

Primary

Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm

A safety composite event is defined as an event that includes one or more of the following: Syncope, Worsening renal function resulting in IV therapy, ultrafiltration, or dialysis, Hypotension and/or hypovolemia resulting in the administration of IV fluids, Clinically significant electrolyte abnormalities resulting in IV replacement or ER/hospitalization for correction, Appropriately detected sustained VT/VF episode, Death

all randomized subjects; intention to treat

Posted

Number

Number of Participants with a Event

Up to five years

ID	Title	Description
OG000	Access Arm	Standard of Care and Cardiac Compass with OptiVol
OG001	Control Arm	Standard of Care alone

Units	Counts
Participants	OG000

Secondary

Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations

To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm

Study was stopped early, therefore secondary objectives were not analyzed.

Posted

up to five years

ID	Title	Description
OG000	Access Arm: Standard of Care and Cardiac Compass With OptiVol	Standard of Care and Cardiac Compass with OptiVol Cardiac Compass with OptiVol Fluid Status Monitoring: Review of Cardiac Compass with OptiVol Fluid Status Monitoring
OG001	Control Arm: Standard of Care Alone	Standard of Care alone Standard of Care alone (clinical assessment): Clinical assessment utilizing standard of care, alone.

Units	Counts
Participants	OG000

Secondary

Cardiovascular Hospitalizations

To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm

The study was stopped early, therefore secondary objectives were not able to be analyzed.

Posted

up to five years

ID	Title	Description
OG000	Access Arm: Standard of Care and Cardiac Compass With OptiVol	Standard of Care and Cardiac Compass with OptiVol Cardiac Compass with OptiVol Fluid Status Monitoring: Review of Cardiac Compass with OptiVol Fluid Status Monitoring
OG001	Control Arm: Standard of Care Alone	Standard of Care alone Standard of Care alone (clinical assessment): Clinical assessment utilizing standard of care, alone.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ATRIAL FLUTTER	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0012 events2 affected58 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected58 at risk
ACUTE DECOMPENSATED HEART FAILURE	Cardiac disorders	MedDRA	Systematic Assessment	EG00040 events17 affected59 at risk EG00131 events11 affected58 at risk
ANEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected59 at risk EG0011 events1 affected58 at risk
ASCITES	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0012 events2 affected58 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
BRADYCARDIA	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
BRONCHITIS	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
CAROTID ARTERY STENOSIS	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
CATARACT	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected58 at risk
CHEST PAIN	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
CHEST PAIN (NON-CARDIAC)	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
CHOLECYSTECTOMY	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected59 at risk EG0010 events0 affected58 at risk
CIRROHSIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
DIGOXIN TOXICITY	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected58 at risk
DRUG INTOLERANCE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
DYSPNEA	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected58 at risk
EDEMATOUS WEIGHT GAIN	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
FOOT ULCER	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
FOREIGN BODY IN GI TRACT	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
GASTROENTERITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
GERD	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
GI BLEED	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
GOUT	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
HYPOTENSION	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected58 at risk
IMPLANT SITE INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
INJURY TO HAND NOS	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
ISCHEMIC HEART DISEASE	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
LEAD CONDUCTOR FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
LUMBAR VERTEBRAL FRACTURE L1	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
NEAR SYNCOPE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
OVERSENSING	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
PARALYTIC ILEUS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
PNEUMONIA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected59 at risk EG0011 events1 affected58 at risk
PYELONEPHRITIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
RECTAL PROLAPSE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected58 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 events4 affected59 at risk EG0014 events4 affected58 at risk
RENAL INSUFFICIENCY	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
SEPSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0012 events2 affected58 at risk
SYNCOPE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected58 at risk
THYROID MASS	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected58 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected59 at risk EG0012 events2 affected58 at risk

ID	Term
D006333	Heart Failure
D006331	Heart Diseases

ID	Title	Description
BG000	Access Arm	Standard of Care and Cardiac Compass with OptiVol
BG001	Control Arm	Standard of Care alone
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Access Arm	Standard of Care and Cardiac Compass with OptiVol			32	59	11	59
EG001	Control Arm	Standard of Care alone			21	58	3	58