Clinical trial NCT01129635: Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging
Official title: Real-Time Intracardiac Impedograms of Left Ventricular Leads to Locate Sites of Latest Mechanical Delay in Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Left Bundle Branch Block
Keywords: Heart failure
Cardiac resynchronization therapy
Regional left ventricular dyssynchrony
CRT
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map.
timeFrame: Acute intraoperative measurement
Secondary outcomes:
measure: Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map.
timeFrame: Acute intraoperative measurement
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Michael S. Lloyd, MD
role: PRINCIPAL_INVESTIGATOR
References:
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