Congestive Heart Failure, LV Dysfunction
Conditions
Brief summary
The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing: 1. Improves the way the heart's left ventricle functions 2. Decreases the number of hospital and clinic visits for heart failure related symptoms 3. Slows the rate patients experience certain heart failure symptoms 4. Reduces uncoordinated heart contractions
Interventions
DEVICEDual Site LV Pacing
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
DEVICEBiV Pacing
Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods.
Sponsors
Medtronic
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy * On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization * A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration \> 120 ms * Left ventricular ejection fraction (LVEF) \< 35% or equal * Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study * Have a life expectancy of more than 180 days, per physician discretion * Age 40 or above, ensuring of legal age to give informed consent specific to state and national law
Exclusion criteria
* Have had previous cardiac resynchronization therapy or a previous coronary venous lead * Unable to perform a Six-Minute Hall Walk (6MHW) Test * Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization * Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.) * Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis) * Have a mechanical tricuspid prosthesis * Has severe aortic or mitral stenosis * Enrolled in any concurrent study that may confound the results of this study * Patients who are or suspect they may be pregnant or plan to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular End Systolic Volume (LVESV) | At 6 months to one year | The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient. |
Countries
United States
Participant flow
Pre-assignment details
Subjects are consented and randomized before the pacing prodecure. They may have been excluded (considered screen fails) if they end up not having the procedure or being identified as inappropriate once the procedure began. 50 Consented and 41 Randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.
Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 to 6 Months | Withdrawal by Subject | 0 | 2 |
| 6 Months to Study Completion | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 10.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 41 | 3 / 41 |
| serious Total, serious adverse events | 3 / 41 | 3 / 41 |
Outcome results
Primary
Change in Left Ventricular End Systolic Volume (LVESV)
The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.
Time frame: At 6 months to one year
Population: Analysis population was based on the two randomized groups per the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Site LV Pacing | Change in Left Ventricular End Systolic Volume (LVESV) | -28.16 ml | Standard Deviation 14.62 |
| BiV Pacing | Change in Left Ventricular End Systolic Volume (LVESV) | -25.91 ml | Standard Deviation 27.84 |