Left Ventricular Lead Position in Cardiac Resynchronization Therapy

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Implantation of a cardiac resynchronization therapy device; Procedure: Echocardiography (myocardial deformation imaging)

• Registration Number: NCT00748735
• Lead Sponsor: RWTH Aachen University

Brief Summary

Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.

Detailed Description

In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.

Study Timeline

• Status Verified: 2008-01
• Study First Submitted: 2008-09-07
• Study First Submitted QC: 2008-09-08
• Last Update Submitted: 2008-09-08
• Study First Posted: 2008-09-09
• Last Update Posted: 2008-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• See above
• Males and females
• Ages 18 to 80 years

Exclusion Criteria

• Patients who already have had a pacemaker device
• Patients with poor echocardiographic window
• Patients who are not able to understand the study and to give informed written consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A1	Echocardiography (myocardial deformation imaging)	heart failure patients undergoing CRT implantation
A1	Implantation of a cardiac resynchronization therapy device	heart failure patients undergoing CRT implantation

Primary Outcome Measures

Name	Time	Method
Improvement in LV function and LV remodelling	6 to 12 months

Trial Locations

Locations (1)

Department of Cardiology, RWTH Aachen University Hospital; 🇩🇪 Aachen, Germany