Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging

January 17, 2015 updated by: Michael S. Lloyd, Emory University

Real-Time Intracardiac Impedograms of Left Ventricular Leads to Locate Sites of Latest Mechanical Delay in Cardiac Resynchronization Therapy

Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a clinical trial using intracardiac impedance signals (impedograms) to assess regional dyssynchrony at various sites of left ventricular (LV) lead placement in humans undergoing CRT device implantation. This study will test the following hypotheses during the funding period:

  1. LV lead impedograms as an implant tool to place leads at sites of latest mechanical delay are feasible and correlate with other means of assessing dyssynchrony.
  2. LV lead impedograms vary significantly depending on LV lead location.
  3. There are several characteristics of LV lead impedograms that correlate with mechanical phenomena of the heart.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with NYHA class III or IV heart failure
  • LVEF ≤ 30%
  • QRS duration ≥ 120 ms

Exclusion Criteria:

  • Not a candidate for CRT implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRT Candidate

Patients with NYHA Class III or IV heart failure; EF ≤ 30% and QRS duration ≥ 120 ms, who are scheduled for CRT surgery.

Intervention: Cardiac Resynchronization Therapy (CRT) implantation
Procedure: Cardiac Resynchronization Therapy (CRT) implantation

The impedance measurement is performed during device implantation following CMR. After the RV and LV leads are inserted, secured and tested, they will be connected to the impedance monitor. Impedance recording of at least ten beats will be acquired and stored for future analysis. Each recording will be tagged with the anatomical location of the LV lead. Subsequently, the LV lead will be moved to a different location and the same procedure will be repeated until accessible coronary sinus sites are exhausted. The ultimate LV lead location is determined by the implanting electrophysiologist and is not constrained by the study protocol. Finally, the LV lead will be tested again and the rest of the implantation procedure will proceed as routine.

Arm: CRT Candidate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map.
Time Frame: Acute intraoperative measurement

Parameter will be recorded for at least 10 consecutive heartbeats during sinus and RV paced rhythm

Ts = The average time from the sensed RV IEGM to the peak of the LV impedance curve
Acute intraoperative measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map.
Time Frame: Acute intraoperative measurement

Ts: The average time from the sensed RV IEGM to the peak of the LV impedance curve.

Tp: The average time from the paced RV IEGM to the peak of the LV impedance curve.

Td: The difference between Ts and Tp (Tp - Ts).
Acute intraoperative measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Michael S. Lloyd, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 17, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00036655
  • ACTSI-EP-001 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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