Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)

NCT ID: NCT01520714

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.

Detailed Description

Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had >1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Medtronic passive fixation LV lead

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Group Type: EXPERIMENTAL

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead

Intervention Type: DEVICE

1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Medtronic 4195 Active Fixation LV Lead

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Group Type: EXPERIMENTAL

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead

Intervention Type: DEVICE

1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Interventions

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead

1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Greater than 18 years of age and able to provide informed consent
• Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology
• Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano
• Willingness to comply with the requirements of the protocol

Exclusion Criteria

• Life expectancy of less than six months
• Plans for or significant possibility of pregnancy during the required follow-up window
• Significant cardiovascular surgery planned within six months following ICD implant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James B DeVille, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor Research Institute - The Heart Hospital Baylor Plano

Locations

The Heart Hospital in Plano

Plano, Texas, United States

Countries

United States

Other Identifiers

009-067

Identifier Type: -

Identifier Source: org_study_id