NCT01193712

Endocardial Pacing in On-table Non-responders in Cardiac Resynchronization Therapy

Non-Responders in Cardiac Resynchronization Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether left ventricular endocardial pacing exhibits a greater acute hemodynamic response during biventricular pacing in patients who do not show this response to standard cardiac resynchronization therapy.

Detailed description

Cardiac resynchronisation therapy (CRT) with biventricular pacemakers and implantable cardiac defibrillators (ICD) has proven to be a valuable therapy in selected patients with systolic heart failure, ameliorating both morbidity and mortality. However, with current selection criteria and implant technique, about 20 to 30 % of patients remain non-responders. Non-responders might be due to failing selection criteria or methodology in casu echocardiography. However, an important number of non-responders may result of sub-optimal positioning of the left ventricular lead, remote from the site of delayed activation. Endocardial left ventricular stimulation may ameliorate the shortcomings of epicardial stimulation. The advantage of an endocardial approach is the absence of phrenic nerve stimulation which regularly complicates epicardial pacing, a more predictable pacing threshold and much less restriction to position the lead in the area of interest. Transseptal left ventricular endocardial pacing has already been used in patients in whom standard epicardial pacing was not applicable.

Conditions

• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	temporary left ventricular endocardial pacing	a temporary pacemaker lead will be introduced through the aortic valve to evaluate the effect of left ventricular endocardial pacing. Four different pacing sites (basal and apical septal, basal and apical lateral) will be investigated with measurement of LV dP/dtmax. Afterwards, the endocardial pacing lead will be removed.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-09-02
• Last updated: 2015-02-03

Locations

1 site across 1 country: Netherlands