Study to Determine the Safety and Feasibility of Utilizing the CD Leycom Pressure/Conductance Catheter to Determine Optimal LV Pacing Site

Withdrawn before enrolling · Phase 1

Conditions studied: Heart Failure

In brief

It is hypothesized that it is both safe and feasible to use an interventional approach to LV lead placement (placing the LV lead guided by acute hemodynamic measurements), and that the LV lead can be placed in a position that is superior to the initial empiric lateral wall LV lead location in less than 30 minutes without significant risk to patients. The time from RV capture to LV activation correlates with the optimal pacing site based on stroke volume \& dP/dt measurements.

Key facts

Study ID

NCT01586884

Run by

Lancaster General Hospital

People needed

0

Starts

2012-04-01

Expected to finish

2014-07-01

Last updated by the study team

2014-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ischemic or non-ischemic cardiomyopathy
• Patient meets all current criteria for CRT (NYHA Class III-IV heart failure, QRS ≥ 120 ms, LVEF ≤ 35%, optimal medical therapy).
• Patient willing/able to sign study informed consent and HIPAA authorization.

You may not qualify if…

• Patient does not meet current criteria for CRT implant
• Mechanical aortic valve
• Left ventricular thrombus
• Aortic stenosis
• No palpable femoral pulse
• Extensive atherosclerotic disease of the aorta
• Serum creatinine > 2.5
• Patient not willing/able to sign study informed consent/HIPAA authorization.

Where it is running

• Lancaster General Hospital — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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