NCT01367691

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

2.5 years

First QC Date

June 1, 2011

Last Update Submit

January 31, 2014

Conditions

Heart Failure

Keywords

CRTheart failureCMRsafety

Outcome Measures

Primary Outcomes (1)

  • improvement in NYHA-class

    6 months

Secondary Outcomes (1)

  • safety of CMR in CRT-patients

    6 months

Interventions

CRT reprogramming (Medtronic CRT)DEVICE

CRT devices will be reprogrammed according to CMR analysis

Also known as: Medtronic CRT devices by Medtronic are eligable to be included in this study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of CRT device
  • CRT non responder

You may not qualify if:

  • pregnancy
  • end-stage renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, University of Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiology

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 7, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

DE(1)