Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders
Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients with CRT.
Goals are to demonstrate that
- differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences in myocardial activation
- differences in LV-RV pacing delays cause differences in LV/RV hemodynamics
and to use these data to optimize CRT.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cardiac MR (CMR) in Cardiac Resynchronization Therapy (CRT) Non-responders: Therapy Optimization by Means of Tissue Characterization, Hemodynamic Analysis and Analysis of Myocardial Activation|
- improvement in NYHA-class [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- safety of CMR in CRT-patients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes.
|Study Start Date:||June 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Device: CRT reprogramming (Medtronic CRT)
CMR will be performed in patients under CRT who are currently not responding to CRT. Different LV-RV delays will be programmed during CMR and LV function and different dyssynchrony parameters will be assessed. Results will be used to determine the optimal LV-RV delay, and CRT-devices will be reprogrammed accordingly. Improvement in NYHA-class/conversion to therapy responder will be determined clinically after 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367691
|University Hospital, University of Bonn|
|Bonn, NRW, Germany, 53105|