Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non... | NCT01367691

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

NCT01367691

Sponsor

University Hospital, Bonn

Status

Terminated

Last Update Posted

Feb 3, 2014Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

CRT reprogramming (Medtronic CRT)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 1, 2011

First Submission Date that Met QC Criteria

Jun 6, 2011

First Posted Date

Jun 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2014

Last Update Posted Date

Feb 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claas P. Naehle, Assistant Professor of Radiology, University Hospital, BonnPrincipal Investigator

Lead Sponsor

University Hospital, BonnOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CRT reprogramming (Medtronic CRT)	Device	CRT devices will be reprogrammed according to CMR analysis		Medtronic CRT devices by Medtronic are eligable to be included in this study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvement in NYHA-class		6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

presence of CRT device
CRT non responder

Exclusion Criteria:

pregnancy
end-stage renal failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, University of Bonn		Bonn	North Rhine-Westphalia	53105	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided