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

NCT ID: NCT01367691

Last Updated: 2014-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CRT reprogramming (Medtronic CRT)

CRT devices will be reprogrammed according to CMR analysis

Intervention Type DEVICE

Other Intervention Names

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Medtronic CRT devices by Medtronic are eligable to be included in this study.

Eligibility Criteria

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Inclusion Criteria

* presence of CRT device
* CRT non responder

Exclusion Criteria

* pregnancy
* end-stage renal failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Claas P. Naehle

Assistant Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital, University of Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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206/10

Identifier Type: -

Identifier Source: org_study_id

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