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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01367691
Recruitment Status : Terminated
First Posted : June 7, 2011
Last Update Posted : February 3, 2014
Information provided by (Responsible Party):
Claas P. Naehle, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: CRT reprogramming (Medtronic CRT) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Intervention Details:
    Device: CRT reprogramming (Medtronic CRT)
    CRT devices will be reprogrammed according to CMR analysis
    Other Name: Medtronic CRT devices by Medtronic are eligable to be included in this study.

Primary Outcome Measures :
  1. improvement in NYHA-class [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. safety of CMR in CRT-patients [ Time Frame: 6 months ]
    pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • presence of CRT device
  • CRT non responder

Exclusion Criteria:

  • pregnancy
  • end-stage renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01367691

University Hospital, University of Bonn
Bonn, NRW, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn

Responsible Party: Claas P. Naehle, Assistant Professor of Radiology, University Hospital, Bonn Identifier: NCT01367691     History of Changes
Other Study ID Numbers: 206/10
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014

Keywords provided by Claas P. Naehle, University Hospital, Bonn:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases