Heart Failure, Congestive
Conditions
Keywords
Heart Failure, Congestive, Implantable Cardioverter-Defibrillators
Brief summary
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.
Interventions
Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who meet the ICD indications * Patients with Class III or IV heart failure. * Patients receiving or who received a Medtronic CRT ICD within the previous 3 months. * Patient must sign and date informed consent, and be 18 years of age or greater. * Patient must be available for follow up visits, and be willing and able to comply with study protocol.
Exclusion criteria
* Patient with acute myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous coronary angioplasty (PTCA)/stent within the last month. * Patient with a mechanical right heart valve. * Patient with chronic (permanent) atrial arrhythmias. * Patient with life expectancy of less than 12 months. * Patient with status post heart transplant * Patient undergoing kidney dialysis * Patients enrolled in a concurrent study that may confound the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Heart Failure (HF) Related Adverse Event (AE) | From 6 month to the 12 month visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU) | 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. |
| Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 157 |
| 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. | 486 |
| No OptiVol Measurement All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available. | 358 |
| Total | 1,001 |
Baseline characteristics
| Characteristic | At Least 1 OptiVol Fluid Index > 100 During DREP | No OptiVol Fluid Index > 100 During DREP | No OptiVol Measurement | Total |
|---|---|---|---|---|
| Age Continuous | 68.8 years STANDARD_DEVIATION 11 | 68.2 years STANDARD_DEVIATION 10.6 | 68.5 years STANDARD_DEVIATION 11 | 68.4 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 157 participants | 486 participants | 358 participants | 1001 participants |
| Sex: Female, Male Female | 45 Participants | 163 Participants | 109 Participants | 317 Participants |
| Sex: Female, Male Male | 112 Participants | 323 Participants | 249 Participants | 684 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 75 / 157 | 172 / 486 | 96 / 358 |
| serious Total, serious adverse events | 84 / 157 | 114 / 486 | 99 / 358 |
Outcome results
Primary
Occurrence of Heart Failure (HF) Related Adverse Event (AE)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| At Least 1 OptiVol Fluid Index > 100 During DREP | Occurrence of Heart Failure (HF) Related Adverse Event (AE) | 29 participants |
| No OptiVol Fluid Index > 100 During DREP | Occurrence of Heart Failure (HF) Related Adverse Event (AE) | 50 participants |
p-value: 0.011995% CI: [1.17, 3.67]Regression, Cox
Secondary
Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)
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.
Time frame: 6 month to the 12 month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| At Least 1 OptiVol Fluid Index > 100 During DREP | Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU) | 22 participants |
| No OptiVol Fluid Index > 100 During DREP | Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU) | 35 participants |
p-value: 0.018595% CI: [1.11, 3.27]Regression, Cox
Secondary
Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)
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.
Time frame: 6 month to the 12 month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| At Least 1 OptiVol Fluid Index > 100 During DREP | Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE) | 17 participants |
| No OptiVol Fluid Index > 100 During DREP | Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE) | 28 participants |
p-value: 0.057895% CI: [0.98, 3.31]Regression, Cox