NCT00764075

Guided Placement of CRT-Leads

CT and 3D-Echocardiography Placement of CRT-Leads

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.

Detailed description

Patients will be allocated to two groups with either 1. Guided implantation of the left ventricular lead 2. Empirical implantation of the left ventricular lead (current clinical standard) For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined. For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC. In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are: 1. Technical success in placing the electrode in the target vessel. 2. Failure due to dislocation during the implantation procedure or phrenic nerve stimulation. Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Beutel TM	application of BeutelTM
OTHER	standard	standard procedure will be applied but no Beutel TM software
DEVICE	software Beutel TM	application of BeutelTM to patients data for determination of site of latest contraction

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2008-10-01
• Last updated: 2011-07-07

Locations

1 site across 1 country: Germany