Back to resultsCardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CRT reprogramming (Medtronic CRT)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring CRT, heart failure, CMR, safety
Eligibility Criteria
Inclusion Criteria:
- presence of CRT device
- CRT non responder
Exclusion Criteria:
- pregnancy
- end-stage renal failure
Sites / Locations
- University Hospital, University of Bonn
Outcomes
Primary Outcome Measures
improvement in NYHA-class
Secondary Outcome Measures
safety of CMR in CRT-patients
pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes.
Full Information
NCT ID
NCT01367691
First Posted
June 1, 2011
Last Updated
January 31, 2014
Sponsor
University Hospital, Bonn
1. Study Identification
Unique Protocol Identification Number
NCT01367691
Brief Title
Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT, heart failure, CMR, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CRT reprogramming (Medtronic CRT)
Other Intervention Name(s)
Medtronic CRT devices by Medtronic are eligable to be included in this study.
Intervention Description
CRT devices will be reprogrammed according to CMR analysis
Primary Outcome Measure Information:
Title
improvement in NYHA-class
Time Frame
6 months
Secondary Outcome Measure Information:
Title
safety of CMR in CRT-patients
Description
pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
presence of CRT device
CRT non responder
Exclusion Criteria:
pregnancy
end-stage renal failure
Facility Information:
Facility Name
University Hospital, University of Bonn
City
Bonn
State/Province
NRW
ZIP/Postal Code
53105
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders
We'll reach out to this number within 24 hrs