Clinical trial NCT01586884: Study to Determine the Safety and Feasibility of Utilizing the CD Leycom Pressure/Conductance Catheter to Determine Optimal LV Pacing Site
Official title: Study to Determine the Safety and Feasibility of Utilizing the CD Leycom Pressure/Conductance Catheter to Determine Optimal LV Pacing Site
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Heart Failure
Keywords: LV Pacing
LV Lead Placement
LV Pacing Site
CRT Device Placement
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background

Cardiac synchronization therapy (CRT) is recognized as effective adjunctive therapy for heart failure; however, up to 40% of patients who undergo CRT device placement do not have a favorable response to therapy and are labeled non-responders. The lateral wall of the left ventricle (LV) is generally regarded as the optimal site for LV lead placement and some non-responders with LV leads not on the lateral wall can be converted to responders by repositioning the LV lead to the lateral wall. However, recent studies indicate that in some patients LV lead placement at a site other than the lateral wall may result in a better response to CRT. In such circumstances, empiric lateral wall lead positioning/repositioning may expose patients to the risks of another invasive procedure (including an increased risk of infection); in the case of lead repositioning to improve response to CRT the additional risk is doubled, as there is no certainty that the new position will be superior to the old.

Several investigators have used the acute hemodynamic response to biventricular pacing to determine the optimal LV lead position. To make these measurements some groups used a Millar pigtail catheter (Millar Instruments, Houston, Texas) while other groups used real-time pressure volume loops with a combined pressure-conductance catheter (CD Leycom, Zoetermeer, the Netherlands). One criticism of this method is that acute hemodynamic measurements may not correlate to long term response. However, Delnoy et al demonstrated that acute improvements in LV function as measured by pressure-volume loops during implantation corresponded to clinical and echocardiographic improvement during follow-up. In addition, Duckett et al demonstrated that the acute dP/dt response to LV pacing is useful for predicting which patients are likely to remodel in response to CRT, for both dilated and ischemic cardiomyopathy.

Despite these observations, few practitioners routinely utilize acute hemodynamic measurements for LV lead placement at the time of device implantation. Many practitioners believe targeted LV lead placement is impractical due to the time required to determine hemodynamic response to CRT and reposition the LV lead, and that venous anatomy, phrenic nerve pacing, and high pacing thresholds severely limit options for LV lead placement.

Study Hypothesis

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.

Study Purpose

The purpose of this study is to determine whether utilizing the CD Leycom pressure-conductance catheter to measure dP/dt and pressure volume loops at the time of LV lead implant (whether for the initial CRT implant or revision of an existing system) is both safe and feasible. It is hoped that the study will determine whether it is possible to use a patient's hemodynamic response to pacing to locate an LV pacing site that provides better hemodynamic response to CRT than the empirically selected lateral wall pacing site without significant patient risk (in terms of radiation exposure, amount of contrast received, procedure time, potential injury).

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

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

Primary outcomes:
measure: Feasibility
timeFrame: 30 Minutes
measure: Procedure time
timeFrame: 2 Hours
measure: Radiation exposure
timeFrame: 2 Hours
measure: Contrast nephropathy
timeFrame: 2 Hours
measure: Death
timeFrame: 1 Month
Secondary outcomes:
measure: Feasibility
timeFrame: 1 Month
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
Study officials:
affiliation: Lancaster General Hospital
name: Seth J Worley, MD
role: STUDY_CHAIR
affiliation: Lancaster General Hospital
name: Susan A Deck, BS RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Douglas Gohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Kay M Knepper, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Kruse Lou Anne, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: McKernan Pulliam Melissa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Pulliam Ward, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Testa Heidi, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spragg DD, Dong J, Fetics BJ, Helm R, Marine JE, Cheng A, Henrikson CA, Kass DA, Berger RD. Optimal left ventricular endocardial pacing sites for cardiac resynchronization therapy in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2010 Aug 31;56(10):774-81. doi: 10.1016/j.jacc.2010.06.014.
citation: Derval N, Steendijk P, Gula LJ, Deplagne A, Laborderie J, Sacher F, Knecht S, Wright M, Nault I, Ploux S, Ritter P, Bordachar P, Lafitte S, Reant P, Klein GJ, Narayan SM, Garrigue S, Hocini M, Haissaguerre M, Clementy J, Jais P. Optimizing hemodynamics in heart failure patients by systematic screening of left ventricular pacing sites: the lateral left ventricular wall and the coronary sinus are rarely the best sites. J Am Coll Cardiol. 2010 Feb 9;55(6):566-75. doi: 10.1016/j.jacc.2009.08.045. Epub 2009 Nov 20.
citation: Delnoy PP, Ottervanger JP, Vos DH, Elvan A, Misier AR, Beukema WP, Steendijk P, van Hemel NM. Upgrading to biventricular pacing guided by pressure-volume loop analysis during implantation. J Cardiovasc Electrophysiol. 2011 Jun;22(6):677-83. doi: 10.1111/j.1540-8167.2010.01968.x. Epub 2010 Dec 6.
citation: Duckett SG, Ginks M, Shetty AK, Bostock J, Gill JS, Hamid S, Kapetanakis S, Cunliffe E, Razavi R, Carr-White G, Rinaldi CA. Invasive acute hemodynamic response to guide left ventricular lead implantation predicts chronic remodeling in patients undergoing cardiac resynchronization therapy. J Am Coll Cardiol. 2011 Sep 6;58(11):1128-36. doi: 10.1016/j.jacc.2011.04.042.