Optimization of A-V and V-V Delay in CRT with surface Electrocardiogram and Impedance Cardiography compared to Echocardiography

Study Status

Open to Enrollment

Study Description

Cardiac resynchronization therapy (CRT) is clinically indicated for patients with severe left ventricular (LV) systolic dysfunction (decreased pumping ability of the heart), medically-refractory heart failure symptoms (shortness of breath, fatigue, swelling due to extra fluid) and intra-ventricular electrical or mechanical conduction delays (slow electrical impulse within the heart). CRT has been shown to improve patient symptoms, increase exercise tolerance, and partially reverses maladaptive LV remodeling.

Numerous studies have examined the effects of left ventricular lead positioning on cardiac function but there is little consensus as to how to determine the optimal position for the individual patient. Moreover, since left ventricular leads are usually placed via tributaries of the coronary sinus, the selection of left ventricular position is confined to the constraints of patient anatomy.

Several recent studies have examined optimizing device programming by altering atrio-ventricular (A-V) and left ventricular-right ventricular (V-V) pacing intervals. Initial studies examining optimization of A-V and V-V pacing intervals utilized echocardiography guided techniques.

However, optimization using echocardiography is associated with a number of potential challenges, including different optimization methods resulting in different optimal settings, the setting found to be optimal during an initial in-office evaluation may not be optimal in the future or when the patient is active. Furthermore, it has been found to be both time consuming and imprecise.

The goal is to compare a surface electrocardiogram (ECG) guided algorithm with Impedance Cardiography (IC) and Echocardiography for optimization of cardiac resynchronization therapy in patients with congestive heart failure. This study seeks to demonstrate that the 12- lead surface ECG and IC can be used for both A-V and V-V optimization of CRT devices.

Sponsor

New York Cardiac Center & Michael Wolk Heart Foundation

Key Eligibility

  • Be able to meet the below criteria for clinically indicated CRT devices:
    • Have an intrinsic QRS duration ≥ 120ms
    • Have a left ventricular ejection fraction ≤ 35% documented from the baseline echo
    • Have been diagnosed with NYHA Class II, II, IV, despite optimal medical therapy

Principal Investigator

Jim Cheung, MD

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For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
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