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

Not Applicable

Completed

• Conditions: Heart Failure, Systolic; Left Bundle Branch Block
• Interventions: Procedure: Cardiac Resynchronization Therapy (CRT) implantation

• Registration Number: NCT01129635
• Lead Sponsor: Emory University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Study Start: 2010-06
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-17
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

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Exclusion Criteria

• Not a candidate for CRT implantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT Candidate	Cardiac Resynchronization Therapy (CRT) implantation	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

Primary Outcome Measures

Name	Time	Method
Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map.	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

Secondary Outcome Measures

Name	Time	Method
Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map.	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).

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States