Congestive Heart Failure
Conditions
Keywords
Congestive Heart Failure (CHF), Cardiac Resynchronization Therapy (CRT), BiVentricular Implantable Cardioverter Defibrillator (BiVICD), Fraction
Brief summary
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
Detailed description
Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had \>1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.
Interventions
DEVICEMedtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.
Sponsors
Medtronic
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 18 years of age and able to provide informed consent * Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology * Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano * Willingness to comply with the requirements of the protocol
Exclusion criteria
* Life expectancy of less than six months * Plans for or significant possibility of pregnancy during the required follow-up window * Significant cardiovascular surgery planned within six months following ICD implant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of Change in Threshold of >1 Volt With Posture Changes | 6 months |
Countries
United States
Participant flow
Recruitment details
Patients required at physician office. Recruiting will be active until 40 patients are randomized.
Participants by arm
| Arm | Count |
|---|---|
| Medtronic Passive Fixation LV Lead Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. | 0 |
| Medtronic 4195 Active Fixation LV Lead Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 3 |
Baseline characteristics
| Characteristic | Total | Medtronic 4195 Active Fixation LV Lead |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 4 participants | 4 participants |
| Age, Categorical Between 18 and 65 years | 7 participants | 7 participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 11 |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 10 participants | 10 participants |
| Region of Enrollment United States | 11 participants | 11 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 0 |
| serious Total, serious adverse events | 3 / 11 | 0 / 0 |
Outcome results
Primary
Evidence of Change in Threshold of >1 Volt With Posture Changes
Time frame: 6 months
Population: Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.