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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement

NCT01405534

Anesthesia

COMPLETED

Application of Intracavity Electrocardiogram Positioning Technique in PICC

NCT05555160

Patients Requiring Peripherally Inserted Central Venous Catheters

UNKNOWN NA

Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector

NCT03279484

Arrythmia, Implatable Cardioverter Defibrillation, Lead

UNKNOWN NA

Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter

NCT03133962

Echocardiography Implantable Chamber

WITHDRAWN NA

Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

NCT07291869

Central Venous Catheter Point of Care Ultrasound (POCUS) Intracavitary Electrocardiogram Guiding +1 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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.

Group Type EXPERIMENTAL

Pressure/Conductance Catheter

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CD Leycom Pressure/Conductance Catheter

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No