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
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, see Learn About Clinical Studies.

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 July 23, 2014