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

Summary

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.

Conditions

• Heart Failure

Interventions

PROCEDURE

Pressure/Conductance Catheter

The physician will obtain right femoral arterial access and advance the pressure/conductance catheter to the LV utilizing the retrograde approach. Baseline dP/dt and stroke volume will be recorded in the patient's presenting rhythm. The dP/dt and stroke volume will be measured during biventricular pacing. Hemodynamic measurements will be made with the tip of the pacing lead in the distal vessel, followed by repeat measurements with the lead positioned in the mid and proximal portions of the initially selected vein. The pacing and hemodynamic measurements will be repeated with the CS lead positioned in two additional veins (if possible). The pressure/conductance catheter will be removed from the left ventricle after 30 minutes, regardless of the number of pacing sites identified/tested. The physician will make the choice of the LV lead placement based on the information gathered up to that point.

Sponsors & Collaborators

• Lancaster General Hospital

  lead OTHER

Principal Investigators

• Seth J Worley, MD · Lancaster General Hospital

• Susan A Deck, BS RN · Lancaster General Hospital

• Douglas Gohn, MD · Lancaster General Hospital

• Kay M Knepper, RN · Lancaster General Hospital

• Kruse Lou Anne, RN · Lancaster General Hospital

• McKernan Pulliam Melissa, MD · Lancaster General Hospital

• Pulliam Ward, MD · Lancaster General Hospital

• Testa Heidi, RN · Lancaster General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• United States

Study Locations