Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders

Not Applicable

Terminated

• Conditions: Heart Failure

• Registration Number: NCT01367691
• Lead Sponsor: University Hospital, Bonn

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• presence of CRT device
• CRT non responder

Exclusion Criteria

• pregnancy
• end-stage renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
improvement in NYHA-class	6 months

Secondary Outcome Measures

Name	Time	Method
safety of CMR in CRT-patients	6 months	pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes.

Trial Locations

Locations (1)

University Hospital, University of Bonn; 🇩🇪 Bonn, NRW, Germany