Trial Outcomes & Findings for PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure (NCT NCT00279955)

NCT ID: NCT00279955

Last Updated: 2012-06-15

Results Overview

Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.

• Recruitment status: COMPLETED
• Target enrollment: 1024 participants
• Primary outcome timeframe: From 6 month to the 12 month visit
• Results posted on: 2012-06-15

Participant Flow

1024 subjects were enrolled in the study from 21 JUN 2004 through 14 FEB 2007 from 100 centers in US. Follow-up data collection ended on 06 MAR 2008.

23 of 1024 subjects exited prior to successful implant due to not meeting in/exclusion criteria, unsucessful implants, missing informed consent form etc. Of the remaining 1001 subjects, 643 subjects had been followed longer than 6 months and had the OptiVol feature save-to-disk data available. Those 643 subjects were used for analyzing objectives.

Participant milestones

Measure	At Least 1 OptiVol Fluid Index > 100 During DREP All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index \> 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Fluid Index > 100 During DREP All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Measurement All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
Overall Study STARTED	157	486	358
Overall Study COMPLETED	157	486	358
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

Baseline characteristics by cohort

Measure	At Least 1 OptiVol Fluid Index > 100 During DREP n=157 Participants All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index \> 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Fluid Index > 100 During DREP n=486 Participants All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Measurement n=358 Participants All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.	Total n=1001 Participants Total of all reporting groups
Age Continuous	68.8 years STANDARD_DEVIATION 11.0 • n=5 Participants	68.2 years STANDARD_DEVIATION 10.6 • n=7 Participants	68.5 years STANDARD_DEVIATION 11.0 • n=5 Participants	68.4 years STANDARD_DEVIATION 10.8 • n=4 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	163 Participants n=7 Participants	109 Participants n=5 Participants	317 Participants n=4 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	323 Participants n=7 Participants	249 Participants n=5 Participants	684 Participants n=4 Participants
Region of Enrollment United States	157 participants n=5 Participants	486 participants n=7 Participants	358 participants n=5 Participants	1001 participants n=4 Participants

PRIMARY outcome

Timeframe: From 6 month to the 12 month visit

Population: Of the 1001 subjects meeting inclusion and exclusion criteria, 643 subjects had been followed longer than 6 months and had the OptiVolTM feature save-to-disk data available. Those 643 subjects were included in this analysis.

Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.

Outcome measures

Measure	At Least 1 OptiVol Fluid Index > 100 During DREP n=157 Participants All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index \> 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Fluid Index > 100 During DREP n=486 Participants All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
Occurrence of Heart Failure (HF) Related Adverse Event (AE)	29 participants	50 participants

SECONDARY outcome

Timeframe: 6 month to the 12 month visit

Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.

Outcome measures

Measure	At Least 1 OptiVol Fluid Index > 100 During DREP n=157 Participants All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index \> 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Fluid Index > 100 During DREP n=486 Participants All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)	22 participants	35 participants

SECONDARY outcome

Timeframe: 6 month to the 12 month visit

Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.

Outcome measures

Measure	At Least 1 OptiVol Fluid Index > 100 During DREP n=157 Participants All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index \> 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Fluid Index > 100 During DREP n=486 Participants All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)	17 participants	28 participants

Adverse Events

At Least 1 OptiVol Fluid Index > 100 During DREP

Serious events: 84 serious events

Other events: 75 other events

Deaths: 0 deaths

No OptiVol Fluid Index > 100 During DREP

Serious events: 114 serious events

Other events: 172 other events

Deaths: 0 deaths

No OptiVol Measurement

Serious events: 99 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Measure	At Least 1 OptiVol Fluid Index > 100 During DREP n=157 participants at risk All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index \> 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Fluid Index > 100 During DREP n=486 participants at risk All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Measurement n=358 participants at risk All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
General disorders Atrial fibrillation	1.3% 2/157 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	2.1% 10/486 • Number of events 11 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.1% 4/358 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Atrial flutter	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.0% 5/486 • Number of events 6 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Atrial tachycardia	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Cardiomyopathy	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Chest pressure/tightness	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.62% 3/486 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.84% 3/358 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Chronic obstructive pulmonary disease	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.62% 3/486 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Dehydration	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.62% 3/486 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Dizziness	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Dyspnea/Shortness of breath	7.6% 12/157 • Number of events 17 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	4.3% 21/486 • Number of events 29 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	5.0% 18/358 • Number of events 21 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Fatigue, tiredness	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Heart failure decompensation	15.3% 24/157 • Number of events 35 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	4.5% 22/486 • Number of events 24 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	6.7% 24/358 • Number of events 30 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Hypertension	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Hypotension	1.9% 3/157 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.82% 4/486 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Ischemic heart disease	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Near (pre) syncope	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders PVC's	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Paroxysymal nocturnal dyspnea	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Pericardial effusion	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.62% 3/486 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Peripheral edema	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.1% 4/358 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
Vascular disorders Peripheral vascular disease	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.84% 3/358 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Pleural effusion	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Pulmonary embolism	1.3% 2/157 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Renal failure	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Shoulder pain/discomfort	0.64% 1/157 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Syncope	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.82% 4/486 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Thrombosis	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
Vascular disorders Vascular heart disease	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
Cardiac disorders Ventricular fibrillation	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Ventricular tachycardia	3.2% 5/157 • Number of events 6 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.6% 8/486 • Number of events 9 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Wheezing	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Worsening cough	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders xOther Intrinsic Rhythm/Conduction Codes	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders yOther patient disease/condition codes	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders zAll "Other" codes	14.6% 23/157 • Number of events 27 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	2.7% 13/486 • Number of events 14 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	5.3% 19/358 • Number of events 19 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.

Other adverse events

Measure	At Least 1 OptiVol Fluid Index > 100 During DREP n=157 participants at risk All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index \> 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Fluid Index > 100 During DREP n=486 participants at risk All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.	No OptiVol Measurement n=358 participants at risk All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
General disorders Arm/hand swelling	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Atrial fibrillation	1.9% 3/157 • Number of events 5 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.2% 6/486 • Number of events 6 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.7% 6/358 • Number of events 6 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Atrial flutter	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.62% 3/486 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Atrial tachycardia	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Cardiomyopathy	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Chest pressure/tightness	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.62% 3/486 • Number of events 5 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Chronic obstructive pulmonary disease	1.3% 2/157 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Dehydration	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Dizziness	2.5% 4/157 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	2.5% 12/486 • Number of events 12 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.1% 4/358 • Number of events 8 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Dyspnea/Shortness of breath	14.6% 23/157 • Number of events 30 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	8.0% 39/486 • Number of events 43 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	5.3% 19/358 • Number of events 23 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Fatigue, tiredness	1.9% 3/157 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	3.3% 16/486 • Number of events 16 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.84% 3/358 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Heart failure decompensation	3.8% 6/157 • Number of events 7 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.6% 8/486 • Number of events 8 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.1% 4/358 • Number of events 6 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Hypertension	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Hypokalemia	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Hypotension	1.9% 3/157 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.1% 4/358 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Near (pre) syncope	1.3% 2/157 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.84% 3/358 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders PVC's	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Palpitations	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.0% 5/486 • Number of events 5 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Paroxysymal nocturnal dyspnea	0.64% 1/157 • Number of events 3 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.82% 4/486 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Pericardial effusion	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Peripheral edema	3.8% 6/157 • Number of events 7 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	3.3% 16/486 • Number of events 20 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	2.8% 10/358 • Number of events 10 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Peripheral vascular disease	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Pleural effusion	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Rash	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/486 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.28% 1/358 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Syncope	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.4% 7/486 • Number of events 7 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Thrombosis	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Ventricular fibrillation	0.00% 0/157 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.4% 7/486 • Number of events 7 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.4% 5/358 • Number of events 5 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Ventricular tachycardia	1.3% 2/157 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.62% 3/486 • Number of events 8 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.7% 6/358 • Number of events 9 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders Wheezing	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.41% 2/486 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.00% 0/358 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders xOther Intrinsic Rhythm/Conduction Codes	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.21% 1/486 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	0.56% 2/358 • Number of events 2 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders yOther Patient Disease/Conduction Codes	0.64% 1/157 • Number of events 1 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.6% 8/486 • Number of events 8 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	1.1% 4/358 • Number of events 4 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.
General disorders zAll "Other" Codes	7.6% 12/157 • Number of events 19 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	3.5% 17/486 • Number of events 20 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.	3.4% 12/358 • Number of events 17 • Those adverse events were collected during the study (0 to 12 month follow-up). All adverse events which resulted in hospitalization are listed as serious adverse events.

Additional Information

CRDM Core Clinical

Medtronic CRDM Clinical Research

Phone: 800-328-2518

Email: medtroniccrmtrials@medtronic.com

Results disclosure agreements

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Restriction type: OTHER