Guided Placement of CRT-Leads (EK138/08)

RWTH Aachen University

Status: Completed

Conditions: Heart Failure

Treatments: Other: standard; Device: software Beutel TM; Device: Beutel TM

Study type: Interventional

Funder types: Other

Identifiers

NCT00764075

CRT-Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Congestive heart failure,
• Ejection fraction <35%,
• Complete left bundle branch block >120ms,
• NYHA II,III or IV

Exclusion criteria

• Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
• Impaired kidney function (GFR <30ml/min;
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

guided implantation of the left ventricular lead

Treatment:

Device: Beutel TM

2

Placebo Comparator group

Description:

standard implantation of the left ventricular lead

Treatment:

Other: standard

Pilot Group

Experimental group

Description:

feasibility of guided placement of CRT-leads in 20 Patients

Treatment:

Device: software Beutel TM