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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Claas P. Naehle, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01367691
First received: June 1, 2011
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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 Intervention
Heart Failure
Device: CRT reprogramming (Medtronic CRT)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • improvement in NYHA-class [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of CRT device
  • CRT non responder

Exclusion Criteria:

  • pregnancy
  • end-stage renal failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367691

Locations
Germany
University Hospital, University of Bonn
Bonn, NRW, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
  More Information

No publications provided

Responsible Party: Claas P. Naehle, Assistant Professor of Radiology, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01367691     History of Changes
Other Study ID Numbers: 206/10
Study First Received: June 1, 2011
Last Updated: January 31, 2014
Health Authority: Germany: Local Institutional Review Board

Keywords provided by University Hospital, Bonn:
CRT
heart failure
CMR
safety

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014