Guided Placement of CRT-Leads - Full Text View

Sponsors and Collaborators:	RWTH Aachen University University of Chicago
Information provided by:	RWTH Aachen University
ClinicalTrials.gov Identifier:	NCT00764075

Purpose

In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.

Condition	Intervention
Heart Failure	Device: Beutel TM Other: standard Device: software Beutel TM

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	CT and 3D-Echocardiography Placement of CRT-Leads

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:

Rate of non-responders regarding ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental guided implantation of the left ventricular lead	Device: Beutel TM application of BeutelTM
2: Placebo Comparator standard implantation of the left ventricular lead	Other: standard standard procedure will be applied but no Beutel TM software
Pilot Group: Experimental feasibility of guided placement of CRT-leads in 20 Patients	Device: software Beutel TM application of BeutelTM to patients data for determination of site of latest contraction

Detailed Description:

Patients will be allocated to two groups with either

Guided implantation of the left ventricular lead
Empirical implantation of the left ventricular lead (current clinical standard)

For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.

For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.

In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:

Technical success in placing the electrode in the target vessel.
Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.

Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Congestive heart failure,
Ejection fraction <35%,
Complete left bundle branch block >120ms,
NYHA II,III or IV

Exclusion Criteria:

Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
Impaired kidney function (GFR <30ml/min;
Pregnant or breastfeeding women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764075

Contacts

Contact: Christian Knackstedt, MD

++49 241 ext 8035624

cknackstedt@ukaachen.de

Locations

Germany, NRW
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, NRW, Germany, 52074

Sponsors and Collaborators

RWTH Aachen University

University of Chicago

Investigators

Principal Investigator:

Christian Knackstedt, MD

RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

More Information

Responsible Party:	RWTH Aachen University ( Christian Knackstedt, MD )
Study ID Numbers:	CRT-Study
Study First Received:	September 26, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00764075
Health Authority:	Germany: Ethics Commission

Keywords provided by RWTH Aachen University:

heart failure; EF<35%; NYHA II, III or IV

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009