Trial Outcomes & Findings for Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf) (NCT NCT00354159)

Last Updated: 2012-08-09

Results Overview

A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.

Recruitment status

COMPLETED

Study phase

Target enrollment

442 participants

Primary outcome timeframe

Within 6 months post-implant

Results posted on

2012-08-09

Participant Flow

Recruitment began on April 28, 2006 and ended on January 14, 2011. All subjects were exited from the study on January 14, 2011. Fifty-three US clinical centers participated in the REDUCEhf study.

Enrolled subjects were required to have a successful implant of the Chronicle® device prior to randomization. 407 subjects had an attempted implant of the Chronicle® ICD (Implantable Cardioverter Defibrillator) (406) or Chronicle IHM (Implantable Hemodynamic Monitor) (1 subject). Of these 407 subjects, 400 were randomized.

Participant milestones

Participant milestones
Measure	Treatment Arm Physicians have access to device-based hemodynamic monitor information to guide patient management	Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Randomized Study Period STARTED	202	198
Randomized Study Period COMPLETED	180	176
Randomized Study Period NOT COMPLETED	22	22
Long-term Follow-up STARTED	180	176
Long-term Follow-up COMPLETED	0	0
Long-term Follow-up NOT COMPLETED	180	176

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm Physicians have access to device-based hemodynamic monitor information to guide patient management	Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Randomized Study Period Withdrawal by Subject	5	3
Randomized Study Period Physician Decision	6	10
Randomized Study Period Lost to Follow-up	4	0
Randomized Study Period Death	7	9
Long-term Follow-up Withdrawal by Subject	9	9
Long-term Follow-up Physician Decision	127	122
Long-term Follow-up Lost to Follow-up	1	0
Long-term Follow-up Death	14	11
Long-term Follow-up Study Closed	29	34

Baseline Characteristics

Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=202 Participants Physicians have access to device-based hemodynamic monitor information to guide patient management	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management	Total n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	151 Participants n=5 Participants	144 Participants n=7 Participants	295 Participants n=5 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants	54 Participants n=7 Participants	105 Participants n=5 Participants
Age Continuous	54.8 years STANDARD_DEVIATION 14.7 • n=5 Participants	54.7 years STANDARD_DEVIATION 14.8 • n=7 Participants	54.7 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	65 Participants n=7 Participants	126 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	133 Participants n=7 Participants	274 Participants n=5 Participants
Region of Enrollment United States	202 participants n=5 Participants	198 participants n=7 Participants	400 participants n=5 Participants
NYHA (New York Heart Association) Classification NYHA Class II	107 participants n=5 Participants	90 participants n=7 Participants	197 participants n=5 Participants
NYHA (New York Heart Association) Classification NYHA Class III	95 participants n=5 Participants	108 participants n=7 Participants	203 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 6 months post-implant

Population: All 406 subjects with an attempted implant of the Chronicle ICD system.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=406 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.	90.5 Percentage of Chronicle ICD Subjects Interval 87.7 to 93.4	—

PRIMARY outcome

Timeframe: 6 months post implant

Population: All subjects with an attempted implant of the Chronicle IHM system were included in this analysis. At the time the study stopped, there was only one subject with an attempted Chronicle IHM implant. Thus this objective was not analyzed.

A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=1 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant	100 Percent of Chronicle IHM subjects Interval 100.0 to 100.0	—

PRIMARY outcome

Timeframe: 12 months post-implant

Population: All randomized subjects

The rate of HF-related events (hospitalizations \>24h, hospitalizations \<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group	0.48 Heart failure related events per year Interval 0.38 to 0.58	0.49 Heart failure related events per year Interval 0.39 to 0.59

SECONDARY outcome

Timeframe: 12 months post-implant

Population: All follow-up from all randomized subjects were included in this analysis.

The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Cumulative Days in the Hospital for Heart Failure	0 Percent days in hospital Interval 0.0 to 22.0	0 Percent days in hospital Interval 0.0 to 43.0

SECONDARY outcome

Timeframe: 12 months post-implant

Population: All randomized follow-up for all randomized subjects.

The rate of CV-related events (hospitalizations \>24h, hospitalizations \<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group	0.77 Cardiovascular related events per year Interval 0.64 to 0.89	0.86 Cardiovascular related events per year Interval 0.71 to 0.98

SECONDARY outcome

Timeframe: 12 months post-implant

Population: All randomized subjects

Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Freedom From All Cause Death or Heart Failure Hospitalization	42 Number of subjects meeting endpoint Interval 0.73 to 0.85	47 Number of subjects meeting endpoint Interval 0.7 to 0.82

SECONDARY outcome

Timeframe: 12 months post-implant

Population: All randomized follow-up from all randomized subjects

All-cause events were defined as hospitalizations, hospitalizations \<24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Relative Risk of All-cause Events	1.18 All cause event rate per year Interval 1.03 to 1.34	1.55 All cause event rate per year Interval 1.36 to 1.72

SECONDARY outcome

Timeframe: 12 months post implant

Population: All randomized follow-up from all randomized subjects were included.

The definitions of worsened, improved, and unchanged are as follows: Worsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF. Improved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score. Unchanged: Subject is neither worsened nor improved.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm. Percent Subjects Improved	51 Percent of Subjects	51 Percent of Subjects
Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm. Percent Subjects Unchanged	19 Percent of Subjects	17 Percent of Subjects
Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm. Percent Subjects Worsened	30 Percent of Subjects	32 Percent of Subjects

SECONDARY outcome

Timeframe: 12 months post implant

Population: All randomized subjects.

Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Health Resource Utilization	0.1 percentage of randomized days Interval 0.0 to 5.3	0.4 percentage of randomized days Interval 0.0 to 35.1

SECONDARY outcome

Timeframe: 12 months post implant

Population: All randomized subjects.

Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Randomized Days Alive Out of Hospital	340 Days Standard Deviation 65	341 Days Standard Deviation 63

SECONDARY outcome

Timeframe: 12 months post implant

Population: All randomized subjects.

Death from any cause during the 12-month randomization period

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Subject Survival	7 number of deaths	9 number of deaths

SECONDARY outcome

Timeframe: 12 months post implant

Population: All randomized subjects.

The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=198 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Medication Usage	1.77 Medication changes per subject month	1.49 Medication changes per subject month

SECONDARY outcome

Timeframe: 12 months post implant

Population: At least 90 days of ePAD data were required for each subject during the 12-month randomized period to be included in the analysis.

The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=191 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=181 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Intracardiac Pressure	22.0 ePAD mm Hg Standard Deviation 5.6	23.3 ePAD mm Hg Standard Deviation 6.5

SECONDARY outcome

Timeframe: 12 months post implant

Population: All Control Arm subjects with at least 90 days of pressure data available during the 12-month randomized follow-up period.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=143 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=38 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events	26.3 ePAD mm Hg Standard Deviation 6.5	22.5 ePAD mm Hg Standard Deviation 6.3

SECONDARY outcome

Timeframe: baseline to 12 months post implant

Population: Subjects were required to have an NYHA functional class assessment at the baseline and 12-month follow-up visit to be included in this analysis.

The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=177 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=173 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize NYHA Functional Class Percent Subjects NYHA Class II Baseline	55 percentage of subjects Interval 36.0 to 51.0	48 percentage of subjects Interval 33.0 to 48.0
Characterize NYHA Functional Class Percent Subjects NYHA Class III Baseline	45 percentage of subjects	52 percentage of subjects
Characterize NYHA Functional Class Percent Subjects NYHA Class I Month 12	24 percentage of subjects	17 percentage of subjects
Characterize NYHA Functional Class Percent Subjects NYHA Class II Month 12	46 percentage of subjects	52 percentage of subjects
Characterize NYHA Functional Class Percent Subjects NYHA Class III Month 12	27 percentage of subjects	28 percentage of subjects
Characterize NYHA Functional Class Percent Subjects NYHA Class IV Month 12	2 percentage of subjects	5 percentage of subjects
Characterize NYHA Functional Class Percent Subjects Improved NYHA Class	44 percentage of subjects	41 percentage of subjects
Characterize NYHA Functional Class Percent Subjects No Change in NYHA Class	45 percentage of subjects	49 percentage of subjects
Characterize NYHA Functional Class Percent Subjects Worsened NYHA Class	12 percentage of subjects	10 percentage of subjects

SECONDARY outcome

Timeframe: baseline to 12 months post implant

Population: Subjects were required to complete the 6-minute hall walk test at both the baseline and 12-month visit to be included in the analysis of this objective.

The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=157 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=153 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Distance Walked in Six Minutes Baseline visit	313.2 distance walked in 6-minutes (meters) Standard Deviation 124.8	308.7 distance walked in 6-minutes (meters) Standard Deviation 133.5
Characterize Distance Walked in Six Minutes 12-month visit	354.5 distance walked in 6-minutes (meters) Standard Deviation 178.8	347.2 distance walked in 6-minutes (meters) Standard Deviation 160.4
Characterize Distance Walked in Six Minutes Change from baseline to 12-months	41.3 distance walked in 6-minutes (meters) Standard Deviation 160.5	38.5 distance walked in 6-minutes (meters) Standard Deviation 154.3

SECONDARY outcome

Timeframe: baseline to 12 months post implant

Population: Subjects were required to have creatinine values available at the baseline and 12-month visit to be included in the analysis of this objective.

Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=175 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=173 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Renal Function at the Baseline and 12-month Visit Baseline eGFR	72.4 mL/min/1.73 m^2 Standard Deviation 26.2	69.8 mL/min/1.73 m^2 Standard Deviation 20.4
Characterize Renal Function at the Baseline and 12-month Visit 12-month eGFR	68.6 mL/min/1.73 m^2 Standard Deviation 27.7	69.2 mL/min/1.73 m^2 Standard Deviation 25.6
Characterize Renal Function at the Baseline and 12-month Visit Change in eGFR from baseline to 12-months	-3.8 mL/min/1.73 m^2 Standard Deviation 22.0	-0.6 mL/min/1.73 m^2 Standard Deviation 19.3

SECONDARY outcome

Timeframe: implant

Population: Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing as part of their ICD implant procedure.

Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=366 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)	99.7 Percentage of subjects with waveforms Interval 98.5 to 100.0	—

SECONDARY outcome

Timeframe: Implant

Population: Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing.

The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=366 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)	98.9 percentage of subjects Interval 97.2 to 99.7	—

SECONDARY outcome

Timeframe: baseline to 12 months post implant

Population: Subjects were required to respond to the baseline and 12-month follow-up visit to be included in the analysis.

The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=177 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=176 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Quality of Life at Baseline and 12-month Visit Baseline MNWHF score	49.7 scores on a scale Standard Deviation 26.4	52.7 scores on a scale Standard Deviation 28.0
Characterize Quality of Life at Baseline and 12-month Visit 12-month MNWHF score	34.0 scores on a scale Standard Deviation 25.6	37.2 scores on a scale Standard Deviation 25.9
Characterize Quality of Life at Baseline and 12-month Visit Change in MNWHF score from baseline	-15.7 scores on a scale Standard Deviation 27.3	-15.6 scores on a scale Standard Deviation 23.7

SECONDARY outcome

Timeframe: 12 months post implant

Population: All 399 subjects successfully implanted with the Chronicle ICD were included in the analysis.

The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm

Outcome measures

Outcome measures
Measure	Chronicle ICD Implanted Subjects n=202 Participants Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.	Control Arm n=197 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Characterize Arrhythmic Events	0.54 VT/VF episodes per subject month Interval 0.43 to 0.64	0.38 VT/VF episodes per subject month Interval 0.29 to 0.47

Adverse Events

Treatment Arm

Serious events: 123 serious events

Other events: 24 other events

Deaths: 0 deaths

Control Arm

Serious events: 136 serious events

Other events: 25 other events

Deaths: 0 deaths

Enrolled, Not Randomized

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Treatment Arm n=202 participants at risk Physicians have access to device-based hemodynamic monitor information to guide patient management	Control Arm n=198 participants at risk Physicians do not have access to device-based hemodynamic monitor information to guide patient management	Enrolled, Not Randomized n=42 participants at risk 42 subjects were enrolled but exited the study prior to randomization
Cardiac disorders CARDIAC FAILURE	11.9% 24/202 • Number of events 45 • Time from enrollment through study closure The study collected all serious adverse events, all cardiovascular related adverse events, all adverse events related to the implanted system, and all adverse events related to the implant or system-modification procedure.	12.6% 25/198 • Number of events 31 • Time from enrollment through study closure The study collected all serious adverse events, all cardiovascular related adverse events, all adverse events related to the implanted system, and all adverse events related to the implant or system-modification procedure.	0.00% 0/42 • Time from enrollment through study closure The study collected all serious adverse events, all cardiovascular related adverse events, all adverse events related to the implanted system, and all adverse events related to the implant or system-modification procedure.

Additional Information

REDUCEhf Clinical Research Specialist

Medtronic CRDM

Phone: 1-800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Medtronic reviews publications to determine if confidential information ("CI") is included. Any such CI is deleted before publication. Medtronic may not censor/interfere with the publication. Investigators may publish single-site publications after a decision by Medtronic that no multi-site study publication will be done or 12 months after the study is closed, whichever is earlier.
Publication restrictions are in place

Restriction type: OTHER