InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:12/29/2018
Start Date:October 1, 2017
End Date:August 30, 2019
Contact:William Cornwell, MD
Email:william.cornwell@ucdenver.edu
Phone:303-724-2085

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Randomized interventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With mechaNical Circulatory Support Devices

The primary reason the investigators are doing this study are to understand how the right
side of the heart functions in heart failure patients with left ventricular assist devices
(LVADs, or "mechanical hearts"). Second, the investigators are interested in understanding
how different pacemaker settings influence function of the heart at rest and activity.


15 patients with advanced HF who have already undergone CF-LVAD implantation.

Inclusion criteria:

1. Have already received CF-LVADs and are clinically stable,

2. Ambulatory outpatients and are fully recovered (at least 3 months) from LVAD
implantation;

3. Presence of a cardiac resynchronization therapy defibrillator (CRT-D) with an
underlying LBBB conduction abnormality.

Exclusion criteria:

1. Individuals with clinical RV failure under resting conditions, defined as
moderate-severely reduced RV systolic function on echocardiography, or

2. Clinical evidence of RV failure (elevated jugular venous pressures, 3 or 4+
[significant] peripheral edema);

3. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral
vascular disease, pulmonary disease); and

4. Patients that do not have a CRT-D device.

10 healthy individuals will serve as a control group to define normal RV function during
exercise.

Inclusion criteria:

1) Persons without a past medical history of cardiovascular disease or related disease such
as:

1. hypertension,

2. diabetes,

3. peripheral vascular disease,

4. arrhythmias,

f. are not taking any cardiac-related medications (e.g. antihypertensive medications).

Exclusion criteria:

1. Individuals requiring systemic anticoagulation with vitamin-K antagonists or
new/direct oral anticoagulants ("NOAC"/"DOAC");

2. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral
vascular disease).
We found this trial at
1
site
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Phone: 303-724-2085
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