Trial Outcomes & Findings for Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial (NCT NCT00382863)

Last Updated: 2012-07-13

Results Overview

A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

220 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2012-07-13

Participant Flow

Subjects were recruited from 29 investigational sites in the US and 6 investigational sites in Canada, between November, 2006 to September, 2009

3 subjects were considered Roll-in (not randomized) and received treatment. Data from these subjects are not included in the results. Seven (7) subjects were randomized to the Treatment group but were not treated due to suspension of the study. These subjects are excluded from the data.

Participant milestones

Participant milestones
Measure	Treatment HeartNet and Optimal Medical/Device Therapy	Control Optimal Medical/Device Therapy alone
Overall Study STARTED	96	114
Overall Study COMPLETED	81	78
Overall Study NOT COMPLETED	15	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment HeartNet and Optimal Medical/Device Therapy	Control Optimal Medical/Device Therapy alone
Overall Study Death	9	9
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	5	25

Baseline Characteristics

Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone	Total n=210 Participants Total of all reporting groups
Age Continuous	55.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	54.5 years STANDARD_DEVIATION 10.8 • n=7 Participants	54.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	35 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	79 Participants n=7 Participants	147 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race (NIH/OMB) Asian	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race (NIH/OMB) Black or African American	16 participants n=5 Participants	20 participants n=7 Participants	36 participants n=5 Participants
Race (NIH/OMB) White	76 participants n=5 Participants	93 participants n=7 Participants	169 participants n=5 Participants
Race (NIH/OMB) More than one race	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA I: Pts w/cardiac disease, w/o activity limit	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA II; Pts w/cardiac disease, slight limits	49 participants n=5 Participants	53 participants n=7 Participants	102 participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA III; Marked limit to physical activity	43 participants n=5 Participants	57 participants n=7 Participants	100 participants n=5 Participants
New York Heart Association (NYHA) Classification NYHA IV; inability to have activity w/o discomfort	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Heart Failure Etiology Non-ischemic	62 participants n=5 Participants	80 participants n=7 Participants	142 participants n=5 Participants
Heart Failure Etiology Ischemic	34 participants n=5 Participants	34 participants n=7 Participants	68 participants n=5 Participants
Heart Failure Etiology Unknown	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Duration of Heart Failure (time)	7.7 years STANDARD_DEVIATION 6.2 • n=5 Participants	6.5 years STANDARD_DEVIATION 5.0 • n=7 Participants	7.1 years STANDARD_DEVIATION 5.6 • n=5 Participants
Cardiac Medications ACE Inhibitors	72 participants n=5 Participants	86 participants n=7 Participants	158 participants n=5 Participants
Cardiac Medications Antiogensin Receptor Blockers	27 participants n=5 Participants	24 participants n=7 Participants	51 participants n=5 Participants
Cardiac Medications Beta Blockers	94 participants n=5 Participants	114 participants n=7 Participants	208 participants n=5 Participants
Cardiac Medications Diuretics (other than Spironolactone)	81 participants n=5 Participants	100 participants n=7 Participants	181 participants n=5 Participants
Cardiac Medications Aldosterone Inhibitors	53 participants n=5 Participants	76 participants n=7 Participants	129 participants n=5 Participants
Cardiac Medications Digoxin	45 participants n=5 Participants	53 participants n=7 Participants	98 participants n=5 Participants
Medical History and Co-Morbidities Systemic Hypertension	49 participants n=5 Participants	53 participants n=7 Participants	102 participants n=5 Participants
Medical History and Co-Morbidities Pulmonary Hypertension	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants
Medical History and Co-Morbidities Diabetes Mellitus	30 participants n=5 Participants	42 participants n=7 Participants	72 participants n=5 Participants
Medical History and Co-Morbidities Chronic Obstructive Pulmonary Disease (COPD)	8 participants n=5 Participants	13 participants n=7 Participants	21 participants n=5 Participants
Medical History and Co-Morbidities Sleep Apnea	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants
Medical History and Co-Morbidities Asthma	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Medical History and Co-Morbidities Coronary Artery Disease with Angioplasty/Stent	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants
Medical History and Co-Morbidities Stroke TIA/Other Thromboembolic Events	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants
Medical History and Co-Morbidities Peripheral Vascular Disease	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Medical History and Co-Morbidities Myocardial Infarction	35 participants n=5 Participants	33 participants n=7 Participants	68 participants n=5 Participants
Medical History and Co-Morbidities Ventricular Tachycardia	28 participants n=5 Participants	40 participants n=7 Participants	68 participants n=5 Participants
Medical History and Co-Morbidities Atrial Fibrillation	22 participants n=5 Participants	28 participants n=7 Participants	50 participants n=5 Participants
Medical History and Co-Morbidities Biventricular Pacemaker	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Medical History and Co-Morbidities Biventricular ICD	41 participants n=5 Participants	57 participants n=7 Participants	98 participants n=5 Participants
Medical History and Co-Morbidities Pacemaker alone	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Medical History and Co-Morbidities ICD alone	42 participants n=5 Participants	45 participants n=7 Participants	87 participants n=5 Participants
Medical History and Co-Morbidities ICD with Bradycardia Pacing Capability	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: The population is intent to treat.

A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline.

Outcome measures

Outcome measures
Measure	Treatment n=83 Participants HeartNet and Optimal Medical/Device Therapy	Control n=91 Participants Optimal Medical/Device Therapy alone
Responder Analysis - Peak Oxygen Uptake (Peak VO2)	31 participants	35 participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: The population is intent to treat.

A participant was considered a "responder" if 6MW distance at 6 months was at least 45 meters more than at baseline.

Outcome measures

Outcome measures
Measure	Treatment n=87 Participants HeartNet and Optimal Medical/Device Therapy	Control n=99 Participants Optimal Medical/Device Therapy alone
Responder Analysis - Six (6) Minute Walk (6MW) Distance	33 participants	25 participants

PRIMARY outcome

Timeframe: baseline to 6 months

Population: The population is intent to treat.

A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score.

Outcome measures

Outcome measures
Measure	Treatment n=93 Participants HeartNet and Optimal Medical/Device Therapy	Control n=101 Participants Optimal Medical/Device Therapy alone
Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score	53 participants	50 participants

PRIMARY outcome

Timeframe: 12 months

Population: The population is intent to treat.

Total number of participants who died within 12 months of enrollment into the trial.

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Number of Participant Deaths	4 participants	5 participants

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat.

Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remained the same as baseline. "Improved" means the participant's functional class improved (became lower in number) by at least one class. "Worsened" means the participant's functional class deteriorated (became higher in number) by at least one class.

Outcome measures

Outcome measures
Measure	Treatment n=91 Participants HeartNet and Optimal Medical/Device Therapy	Control n=103 Participants Optimal Medical/Device Therapy alone
Change in New York Heart Association (NYHA) Functional Class Improved	37 participants	29 participants
Change in New York Heart Association (NYHA) Functional Class Maintained	45 participants	59 participants
Change in New York Heart Association (NYHA) Functional Class Worsened	9 participants	15 participants

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat

The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.

Outcome measures

Outcome measures
Measure	Treatment n=91 Participants HeartNet and Optimal Medical/Device Therapy	Control n=99 Participants Optimal Medical/Device Therapy alone
Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	12.6 score on a scale Standard Deviation 18.2	3.4 score on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat.

The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.

Outcome measures

Outcome measures
Measure	Treatment n=72 Participants HeartNet and Optimal Medical/Device Therapy	Control n=94 Participants Optimal Medical/Device Therapy alone
Change in Left Ventricular Mass	-19.0 grams Interval -119.0 to 81.0	7.0 grams Interval -254.0 to 109.0

SECONDARY outcome

Timeframe: baseline to 12 months

Population: Population is intent to treat.

A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline.

Outcome measures

Outcome measures
Measure	Treatment n=61 Participants HeartNet and Optimal Medical/Device Therapy	Control n=69 Participants Optimal Medical/Device Therapy alone
Responder Analysis - Peak Oxygen Uptake (Peak VO2)	19 participants	21 participants

SECONDARY outcome

Timeframe: baseline to 12 Months

Population: Population is intent to treat

A participant was considered a "responder" if 6MW distance at 12 months was at least 45 meters more than at baseline.

Outcome measures

Outcome measures
Measure	Treatment n=90 Participants HeartNet and Optimal Medical/Device Therapy	Control n=98 Participants Optimal Medical/Device Therapy alone
Responder Analysis - Six (6) Minute Walk (6MW) Distance	33 participants	25 participants

SECONDARY outcome

Timeframe: baseline to 12 months

Population: Population is intent to treat.

A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score.

Outcome measures

Outcome measures
Measure	Treatment n=91 Participants HeartNet and Optimal Medical/Device Therapy	Control n=101 Participants Optimal Medical/Device Therapy alone
Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score	52 participants	43 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Heart Failure Hospitalization - Actuarial Analysis	9 participants	19 participants

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat.

The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.

Outcome measures

Outcome measures
Measure	Treatment n=89 Participants HeartNet and Optimal Medical/Device Therapy	Control n=98 Participants Optimal Medical/Device Therapy alone
Change in Left Ventricular End Diastolic Volume	-3.8 milliliters Interval -108.1 to 127.5	10.9 milliliters Interval -143.7 to 176.3

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat.

The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.

Outcome measures

Outcome measures
Measure	Treatment n=89 Participants HeartNet and Optimal Medical/Device Therapy	Control n=98 Participants Optimal Medical/Device Therapy alone
Change in Left Ventricular End Systolic Volume	-7.0 milliliters Interval -100.5 to 125.0	2.75 milliliters Interval -134.2 to 150.5

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat.

The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.

Outcome measures

Outcome measures
Measure	Treatment n=89 Participants HeartNet and Optimal Medical/Device Therapy	Control n=98 Participants Optimal Medical/Device Therapy alone
Change in Ejection Fraction	0.0 percent Interval -11.0 to 16.0	1.9 percent Interval -18.0 to 21.0

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat.

The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.

Outcome measures

Outcome measures
Measure	Treatment n=86 Participants HeartNet and Optimal Medical/Device Therapy	Control n=99 Participants Optimal Medical/Device Therapy alone
Change in Left Ventricular End Diastolic Diameter	-0.15 centimeters Interval -1.2 to 1.7	0 centimeters Interval -1.3 to 1.9

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Population is intent to treat.

The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.

Outcome measures

Outcome measures
Measure	Treatment n=85 Participants HeartNet and Optimal Medical/Device Therapy	Control n=95 Participants Optimal Medical/Device Therapy alone
Change in Left Ventricular End Systolic Diameter	-0.1 centimeters Interval -1.2 to 2.1	0.1 centimeters Interval -1.8 to 1.9

SECONDARY outcome

Timeframe: 1 day

Population: Population is as treated, treatment only.

"Technical success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Treatment n=93 Participants HeartNet and Optimal Medical/Device Therapy	Control Optimal Medical/Device Therapy alone
Technical Success (Number of Treatment Arm Participants Successfully Implanted)	92 participants	—

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Heart Failure Death	1 participants	3 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Heart Failure Death - Actuarial Analysis	1 participants	3 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Heart Failure Hospitalization	9 participants	19 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
All-Cause Hospitalization	38 participants	45 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
All-Cause Hospitalization - Actuarial Analysis	38 participants	45 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Participants Experiencing Serious Adverse Events	57 participants	47 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Serious Adverse Events - Actuarial Analysis	57 participants	47 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population is intent to treat.

Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.

Outcome measures

Outcome measures
Measure	Treatment n=96 Participants HeartNet and Optimal Medical/Device Therapy	Control n=114 Participants Optimal Medical/Device Therapy alone
Days Alive Out of Hospital	365 days Interval 45.0 to 365.0	365 days Interval 149.0 to 365.0

Adverse Events

Treatment

Serious events: 57 serious events

Other events: 85 other events

Deaths: 0 deaths

Control

Serious events: 47 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Treatment n=96 participants at risk HeartNet and Optimal Medical/Device Therapy	Control n=114 participants at risk Optimal Medical/Device Therapy alone
Cardiac disorders Cardiovascular	65.6% 63/96 • Number of events 117 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	40.4% 46/114 • Number of events 68 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Respiratory, thoracic and mediastinal disorders Respiratory/Pulmonary	33.3% 32/96 • Number of events 38 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	19.3% 22/114 • Number of events 31 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Gastrointestinal disorders Gastrointestinal	7.3% 7/96 • Number of events 11 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	7.9% 9/114 • Number of events 11 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Nervous system disorders Neurology	9.4% 9/96 • Number of events 10 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	2.6% 3/114 • Number of events 3 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Renal and urinary disorders Renal	9.4% 9/96 • Number of events 9 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	4.4% 5/114 • Number of events 5 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Blood and lymphatic system disorders Hematology	6.2% 6/96 • Number of events 7 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	2.6% 3/114 • Number of events 4 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Renal and urinary disorders Genital-urinary	4.2% 4/96 • Number of events 7 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	2.6% 3/114 • Number of events 3 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
General disorders General	49.0% 47/96 • Number of events 97 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	30.7% 35/114 • Number of events 73 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.

Additional Information

Michael Kolber, General Manager, VP of Regulatory Affairs

Paracor Medical, Inc.

Phone: 408-734-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment n=96 participants at risk HeartNet and Optimal Medical/Device Therapy	Control n=114 participants at risk Optimal Medical/Device Therapy alone
General disorders Laryngeal Granuloma	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
General disorders Ileus	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
General disorders Alcohol Withdrawal	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.0% 1/96 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Worsening Heart Failure	4.2% 4/96 • Number of events 4 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Non-Ischemic Atrial/Ventricular Dysrhythmia	10.4% 10/96 • Number of events 14 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	9.6% 11/114 • Number of events 17 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Cardiac Procedure	9.4% 9/96 • Number of events 9 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	9.6% 11/114 • Number of events 12 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Other Cardiac Hospitalization	8.3% 8/96 • Number of events 8 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	8.8% 10/114 • Number of events 12 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Syncope	2.1% 2/96 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	1.8% 2/114 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Myocardial Infarct	0.00% 0/96 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	1.8% 2/114 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Coronary Insufficiency/Acute Coronary Syndrome/Unstable Angina	2.1% 2/96 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.88% 1/114 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Vascular disorders Peripheral Vascular Disease	2.1% 2/96 • Number of events 3 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Vascular disorders Pulmonary or Vascular Emboli	0.00% 0/96 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	1.8% 2/114 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Vascular disorders Stroke	2.1% 2/96 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.88% 1/114 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Vascular disorders Transient Ischemic Attack	0.00% 0/96 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.88% 1/114 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Vascular disorders Non-cardiac vascular surgery	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Vascular disorders Other Vascular Condition (nonspecific)	0.00% 0/96 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.88% 1/114 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
General disorders Non-cardiac/Non-vascular	22.9% 22/96 • Number of events 32 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	21.1% 24/114 • Number of events 36 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Arrythmias	6.2% 6/96 • Number of events 7 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Pericardial Syndrome	5.2% 5/96 • Number of events 5 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Hypotension	5.2% 5/96 • Number of events 5 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Blood Loss	4.2% 4/96 • Number of events 5 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Myocardial Infarction	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders LV Laceration	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Cardiac disorders Chest Pain Syndrome	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Nervous system disorders Stroke	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Renal and urinary disorders Renal Failure/Insufficiency	2.1% 2/96 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.1% 2/96 • Number of events 3 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Respiratory, thoracic and mediastinal disorders Prolonged Ventilation	2.1% 2/96 • Number of events 3 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Respiratory, thoracic and mediastinal disorders Sleep Apnea	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Infections and infestations Bacteremia/Sepsis	5.2% 5/96 • Number of events 5 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Infections and infestations Pneumonia	2.1% 2/96 • Number of events 4 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
General disorders Dehydration	2.1% 2/96 • Number of events 2 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Blood and lymphatic system disorders Anemia	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Gastrointestinal disorders Gastroesophageal Reflux	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Gastrointestinal disorders Gastrointestinal Bleeding	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
Nervous system disorders Neuropathy	1.0% 1/96 • Number of events 1 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.	0.00% 0/114 • Participants were followed up to 3.5 years Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.