Heart Failure
Conditions
Keywords
Ventricular assist device
Brief summary
Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure. However, little is known about RV pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (LVAD). The univentricular support provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart failure patients, yet the incidence of RV failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing may counteract these adverse mechanical alterations, improving RV systolic function and ultimately LVAD function. The investigators will recruit all patients referred for an implantable, continuous flow LVAD at Duke University Medical Center who have an existing implantable dual-chamber cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. Multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, RV function by Echocardiography as well as patient symptoms and functional status.
Interventions
DEVICEImplantable Cardioverter-Defibrillator (subject's pre-existing ICD)
Pacing parameters set to AAI 90
Sponsors
Medtronic
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old, both men and women * Existing implantable cardioverter-defibrillator (ICD) * Referred for implantation of a continuous flow LVAD
Exclusion criteria
* Permanent left ventricular epicardial defibrillator in place * Congenital heart disease with single ventricle physiology * Right ventricular assist device (RVAD) in place * Existing pacing indication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospitalization | 14 days | To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Need for Hemodynamic / Respiratory Support | 14 days | To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions. |
| Right Ventricular Function | 14 days | To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course. |
| Functional Capacity and Symptoms | 14 days | To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period. |
Countries
United States
Participant flow
Pre-assignment details
One subject provided initial consent but withdrew his consent prior to undergoing left ventricular assist device implantation. No further research activities for the study were performed with respect to this subject.
Participants by arm
| Arm | Count |
|---|---|
| Continuous RV Pacing Study terminated early due to recruitment | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Continuous RV Pacing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 2 |
Outcome results
Primary
Length of Hospitalization
To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.
Time frame: 14 days
Population: Study terminated early
Secondary
Functional Capacity and Symptoms
To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.
Time frame: 14 days
Population: Study terminated early due to low accrual. No data analysis completed.
Secondary
Post-operative Need for Hemodynamic / Respiratory Support
To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.
Time frame: 14 days
Population: Study terminated early due to low accrual. No data analysis completed.
Secondary
Right Ventricular Function
To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.
Time frame: 14 days
Population: Study terminated early due to low accrual. No data analysis completed.