Endocardial Pacing in On-table Non-responders in Cardiac Resynchronization Therapy
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Non-Responders in Cardiac Resynchronization Therapy|
- change in acute hemodynamic response to CRT defined as an increase in LV dP/dtmax of ≥10% during left endocardial pacing compared to left epicardial pacing. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
- improvement in NYHA functional class ≥1 [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
- decrease in MLWHFQ of ≥9 points [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
- decrease in LVESV of ≥15% [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
- increase in LVEF of ≥5% [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
patients who do not show an improvement of more than or equal to 15% in LV dP/dtmax measured immediately after implantation of a cardiac resynchronization therapy device
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.
No Intervention: on-table responders
patients who do show an improvement of more than or equal to 15% in LV dP/dtmax measured immediately after implantation of a cardiac resynchronization therapy device
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193712
|Principal Investigator:||Patrick Houthuizen, MD||Catharina Ziekenhuis Eindhoven|