NCT01586884

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2012

Typical duration for phase_1 heart-failure

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

2.2 years

First QC Date

April 20, 2012

Last Update Submit

September 8, 2014

Conditions

Heart Failure

Keywords

LV PacingLV Lead PlacementLV Pacing SiteCRT Device Placement

Outcome Measures

Primary Outcomes (5)

  • Feasibility

    Feasibility of measuring dP/dt in a maximum of 3 veins within 30 minutes.

    30 Minutes

  • Procedure time

    Additional procedure time for pressure measures.

    2 Hours

  • Radiation exposure

    During procedure as measured with Gafchromic film.

    2 Hours

  • Contrast nephropathy

    From procedure.

    2 Hours

  • Death

    From procedure.

    1 Month

Secondary Outcomes (1)

  • Feasibility

    1 Month

Study Arms (1)

Intervention

EXPERIMENTAL

Ten patients undergoing LV lead placement for either initial CRT device implant or revision of an existing system at Lancaster General Hospital who meet the inclusion and exclusion criteria will be screened and approached for enrollment in this safety and feasibility study. Study participants may have ischemic or non-ischemic cardiomyopathy; results for ischemic and non-ischemic patients will be analyzed separately. Any device system from any manufacturer may be used; the choice of device and leads will be at the implanting physician's discretion. Post implant procedures will be the same as those for any CRT implant. Outpatient follow-up other than the 1-month follow-up will be per the implanting physician's usual practice.

Procedure: Pressure/Conductance Catheter

Interventions

Pressure/Conductance CatheterPROCEDURE

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.

Also known as: CD Leycom Pressure/Conductance Catheter
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (4)

  • 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.

    PMID: 20797490BACKGROUND

  • 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.

    PMID: 19931364BACKGROUND

  • 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.

    PMID: 21134027BACKGROUND

  • 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.

    PMID: 21884950BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Pressure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Seth J Worley, MD

    Lancaster General Hospital

    STUDY CHAIR

  • Susan A Deck, BS RN

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR

  • Douglas Gohn, MD

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR

  • Kay M Knepper, RN

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR

  • Kruse Lou Anne, RN

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR

  • McKernan Pulliam Melissa, MD

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR

  • Pulliam Ward, MD

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR

  • Testa Heidi, RN

    Lancaster General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 27, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

US(1)