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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01367691
• Other study ID #: 206/10
• Status: Terminated
• Phase: N/A
• First received: June 1, 2011
• Last updated: January 31, 2014
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Local Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• presence of CRT device

• CRT non responder

Exclusion Criteria:

• pregnancy

• end-stage renal failure

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRT reprogramming (Medtronic CRT)
CRT devices will be reprogrammed according to CMR analysis

Locations

Country	Name	City	State
Germany	University Hospital, University of Bonn	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in NYHA-class		6 months	No
Secondary	safety of CMR in CRT-patients	pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes.	6 months	Yes