NCT01129635

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure, Systolic
• Left Bundle Branch Block

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2010-05-24
• Last updated: 2015-01-21

Locations

1 site across 1 country: United States